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Buyers Guide 2021

Page 1

Resources for You, Your Patients, & Your Practice


PUBLISHED BY Medical Education Resources, LLC PUBLISHER Aaron R. Medaris amedaris@physiciansofficeresource.com

CEO Andrew C. Nimmo acnimmo@physiciansofficeresource.com

PRESIDENT John D. Pasquale jpasquale@pharmaconnect.com

Getting the most from this guide

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TRAVEL EDITOR Brandi L. Brower EDITORIAL BOARD Michael Paquin, FHIMSS Barry Craig, MLT (NCA), CLC STAFF WRITER Dylan J. Chadwick

There are two simple ways to request

CREATIVE DIRECTOR PRODUCTION MANAGER Jessica Peterson

information about the products and services

Copyright ©2021

found in Physicians Office Resource. 1. Go to www.PhysiciansOfficeResource.com and enter the four-digit reference number found next to the product or service into the search field, then request additional information, schedule a demo, or speak with a sales agent all with just a simple click of a button. 2. Find the Business Reply Card in this issue, circle the desired reference numbers, complete the form, and drop into any USPS mailbox. A representative will contact you as quickly as possible to answer your questions.

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2 | PHYSICIANS OFFICE RESOURCE

To continue your free subscription of Physicians Office Resource magazine, please fill out the Business Reply Card (BRC) located within this magazine and drop in any United States Post Office mailbox. If you are a manufacturer of medical products or provide services to medical professionals and would like to advertise your products or services to the nation’s top physicians doing in-office testing, call 801-380-6094 or visit: POR.io for more information.


THE INFORMATION YOU NEED. THE SIZE YOU WANT. CELL-DYN EMERALD 22 Compact, easy-to-use 5-part differential hematology analyzer offers big lab results with small lab requirements. A small footprint, low reagent consumption and convenient features like touch-screen technology, automatic startup, shutdown and cleaning make it the ideal choice where space and specialized staff are limited. C O M PA C T D E S I G N Conserving valuable laboratory workspace with a small footprint and only 2 reagents plus on-board cleaner.

8700

EASE OF USE • Decreasing manual entry errors and increasing compliance by use of barcoded reagents • Reducing hands-on time with touch-free scheduled daily maintenance, startup and shutdown

F L E X I B L E U S E R I N T E R FAC E • Improving use and easing training of software functions with color touch screen and numeric keypad • Providing positive patient identification with barcode reader for specimens

RELIABILIT Y Helping you keep your commitments

O P T I C A L 5-PA R T D I F F E R E N T I A L Delivering comprehensive results for your doctors and patients

Learn how the CELL-DYN Emerald 22 can help your laboratory operate more efficiently at:

COREL ABORATORY.ABBOT T/HEMATOLOGY ©2020 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners.

For in vitro diagnostic only. Refer to the Operator’s Manual for operational precautions, limitations, and hazards. ADD-00073919 12/20.


2021 · BUYERS GUIDE —

WHAT’S IN THIS GUIDE 6 2021 Medical Conferences 12 Diagnostics and Device Company Directory 20 Health Agency Hotlines 27 Government Organizations 28 S tate Medical Associations 30 C ompanies by Category 37 P roduct Guide

4 | PHYSICIANS OFFICE RESOURCE


Stronger Clinical Performance Takes Lateral Flow Testing To The Next Level

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Providing superior rapid results at the point-of-care. Fast, easy, cost effective so you can test and treat in one visit. High Performance Equivalent to or exceeding the performance of reader devices, without the need for an instrument

SENSITIVITY

SPECIFICITY

Results in 10 minutes OSOM® Custom Care Exceptional Support/Training by licensed medical technologists and experienced healthcare professionals Made in the USA Award-winning supply chain capabilities For more information call 888-616-0537, Option 2, or visit us at www.osomtests.com.

MADE IN THE USA

© 2020 Sekisui Diagnostics, LLC. All rights reserved. OSOM® is a registered trademark of Sekisui Diagnostics, LLC. Because every result matters™ is a trademark of Sekisui Diagnostics, LLC.

8701


MEDICAL CONFERENCES

DIRECTORIES

2021

MEDICAL conferences —

JANUARY

Society of Critical Care Medicine January 31 – February 12, 2021 Virtual Meting 847-827-6888 www.sccm.org

Pri-Med – PrimaryCareNow January 14, 2021 Virtual Meeting 877-477-4633 www.pri-med.com

FEBRUARY

American Association for Hand Surgery 2021 Annual Meeting January 10 – 21, 2021 Virtual Meeting 978-927-8330 www.handsurgery.org

CANS Annual Meeting 2021 California Association of Neurological Surgeons January 15 - 17, 2021 Venue to be Determined 916-457-2267 www.cans1.org American Society for Reconstructive Microsurgery Annual Meeting 2021 January 16 – 17, 2021 Virtual Meeting 312-456-9579 www.microsurg.org STS Annual Meeting Society of Thoracic Surgeons January 29 – 31, 2021 Virtual Meeting 312-202-5800 www.sts.org SCCM Critical Care Congress 6 | PHYSICIANS OFFICE RESOURCE

ORS 2021 Annual Meeting Orthopaedic Research Society February 12 – 16, 2021 Virtual Meeting 847-823-5770 www.ors.org/2021annualmeeting/ Biophysical Society Annual Meeting 2021 Biophysical Society February 22 – 26, 2021 Virtual Meeting 240-290-5600 www.biophysics.org/ 2021meeting 2021 AAAAI Annual Meeting American Academy of Allergy Asthma & Immunology February 26 – March 1, 2021 Virtual Meeting 414-272-6071 www.annualmeeting. aaaai.org

MARCH

SSO 2021 Annual Cancer

Symposium Society of Surgical Oncology March 18 – 19, 2021 Virtual Meeting 847-427-1400 www.surgonc.org AAD Annual Meeting 2021 American Academy of Dermatology March 19 – 23, 2021 – CANCELLED San Francisco, CA 866-503-7546 www.aad.org/meetings/ annual-meeting

CLMA – KnowledgeLab 2021 Clinical Lab Manager Association March 21 – 23, 2021 Nashville, TN 312-321-5111 www.clma.org

APRIL

AACR Annual Meeting 2021 American Association of Cancer Research April 10 – 15, 2021 Virtual Meeting 866-423-3965 www.aacr.org

SGO 2021 Annual Meeting on Women’s Cancer Society of Gynecologic Oncologists March 19 – 25, 2021 Virtual Meeting 312-235-4060 www.sgo.org

AANS Annual Scientific Meeting 2021 American Association of Neurological Surgeons April 17 – 21, 2021 Vancouver, BC 847-378-0500 www.aans.org

ENDO Annual Meeting 2021 The Endocrine Society March 20 – 23, 2021 Virtual Meeting 888-363-6274 www.endocrine.org

AAN Annual Meeting 2021 American Academy of Neurology April 17 – 22, 2021 San Francisco, CA 800-879-1960 www.aan.com

SIR 2021 Annual Scientific Meeting Society of Interventional Radiology March 20 – 26, 2021 Virtual Meeting 800-488-7284 www.SIRmeeting.org

ARRS Annual Meeting 2021 American Roentgen Ray Society April 18 – 22, 2021 Virtual Meeting 866-940-2777


www.arrs.org AMGA Annual Conference 2021 American Medical Group Association April 20 – 21, 2021 Virtual Meeting 703-838-0033 www.amga.org ASLMS 2021 Annual Conference American Society for Laser Medicine & Surgery April 24 – 25, 2021 Virtual Meeting 877-258-6028 www.aslms.org ASBS Annual Meeting 2021 American Society of Breast Surgeons April 28 – May 2, 2021 Orlando, FL 877-992-5470 www.breastsurgeons.org ACP Internal Medicine Meeting 2021 American College of Physicians April 29 – May 1, 2021 Virtual Meeting 800-523-1546 annualmeeting.acponline. org ASAPS Aesthetic Meeting 2021 The American Society for Aesthetic Plastic Surgery April 29 – May 3, 2021 Miami Beach, FL 800-364-2147 www.surgery.org AATS Annual Meeting 2021 American Association for Thoracic Surgery April 30 – May 2, 2021 Virtual Meeting 978-927-8330 www.aats.org ACOG 2021 Annual Clinical and Scientific Meeting American College of Obstetricians and Gynecologists

April 30 – May 3, 2021 Washington, DC 800- 673-8444 www.acog.org

MAY

ATS 2021 International Conference American Thoracic Society May 14 – 19, 2021 San Diego, CA 212-315-8600 conference.thoracic.org AAC 2021 Annual Scientific Session and Expo American College of Cardiology May 15 – 17, 2021 Atlanta, GA 800-253-4636 accscientificsession.acc. org ACR Annual Meeting 2021 American College of Radiology May 15 – 19, 2021 Virtual Meeting 800-243-7419 www.acr.org/annual-meeting ASNR Annual Meeting & The Foundation of the ASNR Symposium 2021 American Society of Neuroradiology May 22 – 27, 2021 San Francisco, CA 630-574-0220 www.asnr.org AACE 2021 Annual Scientific & Clinical Congress American Association of Clinical Endocrinologists May 26 – 29, 2021 Las Vegas, NV 904-353-7878 www.aace.com

JUNE

ACSM Annual Meeting American College of Sports Medicine June 1 – 5, 2021 Washington, DC 317-637-9200 www.acsmannualmee-

ting.org SNMMI 2021 Annual Meeting Society of Nuclear Medicine & Molecular Imaging June 12 – 15, 2021 Washington, DC 703-708-9000 www.snmmi.org AMA Annual Meeting of House of Delegates 2021 American Medical Association June 12 – 16, 2021 Chicago, Illinois 800-621-8335 www.ama-assn.org BIO International Convention 2021 Biotechnology Industry Organization June 14 – 17, 2021 TBD 202-962-6655 bio.org/ SAGES 2021 Annual Meeting Society of American Gastrointestinal Endoscopic Surgeons June 15 – 18, 2021 Las Vegas, NV 310-437-0544 www.sages2021.surgery Pri-Med Southwest 2021 June 17 – 19, 2021 Houston, TX 877-774-6338 www.pri-med.com APIC Annual Conference 2021 Association for Professional in Infection Control and Epidemiology June 28 – 30, 2021 Austin, TX 202-789-1890 ac2021.site.apic.org

JULY

AANA Annual Congress 2021 Arthroscopy Association of North America July 7 – 11, 2021 Nashville, TN 847-292-2262 www.aana.org

AAPM Annual Meeting 2021 American Association of Physicists in Medicine July 25 – 29, 2021 Columbus, OH 571-298-1300 www.aapm.org AACC 2021 Annual Meeting & Clinical Lab Expo American Association for Clinical Chemistry July 25 – 29, 2021 Anaheim, CA 800-892-1400 www.aacc.org

AUGUST

Pri-Med West 2021 August 4 – 7, 2021 Anaheim, California 877-774-6338 www.pri-med.com AORN Global Surgical Conference & Expo 2021 Association of Perioperative Registered Nurses August 7 – 11, 2021 Orlando, FL 800-755-2676 www.aorn.org 2021 Annual HIMSS Conference & Exhibition Healthcare Information and Management Systems August 9 – 13, 2021 Las Vegas, NV 855-326-8342 www.himssconference. org PDA Annual Meeting Pacific Dermatologic Association August 19 – 22, 2021 Lake Tahoe, CA 888-388-8815 www.pacificderm.org AAOS Annual Meeting 2021 American Academy of Orthopaedic Surgeons August 31 – September 3, 2021 San Diego, CA 847-823-7186 www.aaos.org

2021 · BUYERS GUIDE | 7


MEDICAL CONFERENCES

DIRECTORIES

SEPTEMBER

FMX 2021 American Academy of Family Physicians September 28 – October 2, 2021 Anaheim, CA 800-274-2237 www.aafp.org

OCTOBER

NASS 2021 Annual Meeting North American Spine Society October 7 – 10, 2021 San Diego, CA 630-230-3600 www.spine.org The ANESTHESIOLOGY 2021 Annual Meeting American Society of Anesthesiologists October 9 – 13, 2021 San Diego, CA 847-825-5586 www.asahq.org ASRM Scientific Congress and Expo 2021 American Society for Reproductive Medicine October 16 – 20, 2021 Baltimore, MD

205-978-5000 www.asrm.org CNS Annual Meeting 2021 Congress of Neurological Surgeons October 16– 20, 2021 Austin, TX 847-240-2500 www.cns.org ASTRO Annual Meeting 2021 American Society for Therapeutic Radiology & Oncology October 24 – 27, 2021 TBD 703-502-1550 www.astro.org CHEST 2021 ACCP Annual Meeting American College of Chest Physicians October 24 –27, 2021 Vancouver, BC 800-343-2227 www.chestnet.org ACEP Annual Scientific Assembly 2021 American College of Emergency Physicians October 25 – 28, 2021

Boston, MA 800-798-1822 www.acep.org ASHG 2021 American Society of Human Genetics October TBD TBD 301-634-7300 www.ashg.org

NOVEMBER

ISPE Annual Meeting 2021 International Society for Pharmaceutical Engineering November 1 – 3, 2021 Boston, MA 301-364-9201 www.ispe.org ACAAI 2021 Annual Meeting American College of Allergy Asthma & Immunology November 4 – 8, 2021 New Orleans, LA 847-427-1200 www.acaai.org AAO Annual Meeting 2021

American Academy of Ophthalmology November 13 – 15, 2021 New Orleans, LA 415-561-8500 www.aao.org RSNA 2021 Scientific Assembly and Annual Meeting Radiological Society of North America November 28 – December 2, 2021 Chicago, Illinois 800-381-6660 www.rsna.org

DECEMBER

No Conferences

CONFERENCES WITH DATES TO BE DETERMINED AAPM Annual Meeting American Academy of Pain Medicine TBD Virtual Meeting 847-375-4731 www.annualmeeting.painmed.org

EMR Compatable 12 Lead EKG with Interpretation (For iPad, iPhone & other Devices) MOBILE DEVICES!

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8702

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8 | PHYSICIANS OFFICE RESOURCE

New iPad EKG

EKG w/ interp.

Manufactured in USA by:


POINT OF CARE

E

E

N

U

B

L

M

8703

EHENS PR I M

VE

CO

TRANSFORM PATIENT SATISFACTION AND PRACTICE EFFICIENCY.

AVA I L A

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CLIA Waived Tests: CMP, BMP, Lipid Panel, Lipid Panel Plus, General Chemistry, Kidney Check, Renal Panel, MetLyte 8 and Electrolytes

8704

Fast—Results in minutes, accelerating patient care decisions. Accurate—Lab-accurate results for a wide range of tests.* Versatile—Comprehensive CLIA-waived menu available. Simple—Intuitive function to improve operational efficiency. Convenient—Have test results during office visit, increasing patient satisfaction.

To learn more, contact your Abbott Point of Care representative at 888-893-0335, your distribution representative, or visit www.pointofcare.abbott *2016 Proficiency Testing Results, American Proficiency Institute, www.api-pt.com [Piccolo Xpress]. See cartridge information at www.pointofcare.abbott [i-STAT]. i-STAT Part No: 04J60-20 Waived Kit, 04J48-50 Moderately Complex Kit, 06F20-20 Waived Analyzer, 04P75-03 Moderately Complex Analyzer Piccolo Xpress Part No: 07P05-50 Piccolo Xpress with 3YR Serv, 07P05-51 Piccolo Xpress with 5YR Serv ©Abbott Point of Care Inc. 400 College Road East, Princeton, NJ 08540 www.pointofcare.abbott For in vitro diagnostic use only. This material is intended for a U.S. audience only. i-STAT is a trademark of Abbott. 3032.REV1 07/20 POR Ad - Abbott POC i-Stat/Piccolo Piccolo Xpress is a registered trademark of Abaxis, Inc. and distributed by Abbott Point of Care. Abaxis 888-3355 Rev A


AJOVY IS AVAILABLE IN AN AUTOINJECTOR

AJOVY is indicated for the preventive treatment of migraine in adults

FEATURES OF THE EASY-TO-USE AUTOINJECTOR1

No visible needle

97%

Audible cues signal progress of administration

Window displays when dose has been delivered

of HCP and patient evaluators found the AJOVY Autoinjector easy to use in two human factor studies (N=77)1*

Please provide proper training to patients and/or caregivers on the preparation and administration of the AJOVY Autoinjector, as well as the prefilled syringe. Available resources include Instructions for Use in the full Prescribing Information, and an IFU video can be accessed at AJOVYhcp.com.

4

x

PER YEAR

Only 4 injection days per year with quarterly dosing

AJOVY can also be administered monthly

IMPORTANT SAFETY INFORMATION

Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients. Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy. Adverse Reactions: The most common adverse reactions (≥5% and greater than placebo) were injection site reactions. Please see the Brief Summary of the full Prescribing Information on the adjacent page.

*Two human factor studies assessed evaluators’ ability to complete critical tasks in order to demonstrate use of the AJOVY Autoinjector in simulated-use sessions. When asked “Was the autoinjector easy to use?”, 97% in study 1 (N=30) and 98% in study 2 (N=47) answered “Yes.”1

Reference: 1. Data on file. Parsippany, NJ: Teva Pharmaceuticals USA, Inc.

To learn more, visit AJOVYhcp.com © 2020 Teva Pharmaceuticals USA, Inc. FRE-43159 October 2020


BRIEF SUMMARY OF PRESCRIBING INFORMATION FOR AJOVY® (fremanezumab-vfrm) injection, for subcutaneous use SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION INDICATIONS AND USAGE 1 AJOVY is indicated for the preventive treatment of migraine in adults. DOSAGE AND ADMINISTRATION 2 2.1 Recommended Dosage Two subcutaneous dosing options of AJOVY are available to administer the recommended dosage: • 225 mg monthly, or • 675 mg every 3 months (quarterly), which is administered as three consecutive subcutaneous injections of 225 mg each. When switching dosage options, administer the first dose of the new regimen on the next scheduled date of administration. If a dose of AJOVY is missed, administer as soon as possible. Thereafter, AJOVY can be scheduled from the date of the last dose. Important Administration Instructions 2.2 AJOVY is for subcutaneous use only. AJOVY may be administered by healthcare professionals, patients, and/or caregivers. Prior to use, provide proper training to patients and/or caregivers on the preparation and administration of AJOVY prefilled syringe, including aseptic technique [see Instructions for Use in full Prescribing Information]: • Remove AJOVY from the refrigerator. Prior to use, allow AJOVY to sit at room temperature for 30 minutes protected from direct sunlight. Do not warm by using a heat source such as hot water or a microwave. Do not use AJOVY if it has been at room temperature for 24 hours or longer. • Follow aseptic injection technique every time AJOVY is administered. • Inspect AJOVY for particles or discoloration prior to administration. Do not use if the solution is cloudy, discolored, or contains particles. • Administer AJOVY by subcutaneous injection into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated. For multiple injections, you may use the same body site, but not the exact location of the previous injection. • Do not co-administer AJOVY with other injectable drugs at the same injection site. 4 CONTRAINDICATIONS AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumabvfrm or to any of the excipients [see Warnings and Precautions (5.1)]. 5 WARNINGS AND PRECAUTIONS 5.1 Hypersensitivity Reactions Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria, were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. If a hypersensitivity reaction occurs, consider discontinuing AJOVY, and institute appropriate therapy. ADVERSE REACTIONS 6 The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: • Hypersensitivity Reactions [see Warnings and Precautions (5.1)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in clinical practice. The safety of AJOVY was evaluated in 2512 patients with migraine who received at least 1 dose of AJOVY, representing 1279 patient-years of exposure. Of these, 1730 patients were exposed to AJOVY 225 mg monthly or AJOVY 675 mg quarterly for at least 6 months, 775 patients for at least 12 months, and 138 patients for at least 15 months. In placebo-controlled clinical trials (Studies 1 and 2), 662 patients received AJOVY 225 mg monthly for 12 weeks (with or without a loading dose of 675 mg), and 663 patients received AJOVY 675 mg quarterly for 12 weeks. In the controlled trials, 87% of patients were female, 80% were White, and the mean age was 41 years. The most common adverse reactions in the clinical trials for the preventive treatment of migraine (incidence at least 5% and greater than placebo) were injection site reactions. The adverse reactions that most commonly led to discontinuations were injection site reactions (1%). Table 1 summarizes adverse reactions reported in the 3-month placebo-controlled studies (Study 1 and Study 2), and the 1-month follow-up period after those studies. Table 1: Adverse Reactions Occurring with an Incidence of At Least 2% for Either Dosing Regimen of AJOVY and At Least 2% Greater Than Placebo in Studies 1 and 2 Placebo AJOVY AJOVY Monthly 225 mg Monthly 675 mg Quarterly (n=668) (n=667) (n=290) % % % Injection site reactionsa 43 45 38 a Injection site reactions include multiple related adverse event terms, such as injection site pain, induration, and erythema. Adverse Reaction

AJOVY® (fremanezumab-vfrm) injection 6.2 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to fremanezumab-vfrm in the studies described below with the incidence of antibodies in other studies to other products may be misleading. Clinical immunogenicity of AJOVY was monitored by analyzing anti-drug antibodies (ADA) and neutralizing antibodies in drug-treated patients. The data reflect the percentage of patients whose test results were positive for antibodies to AJOVY in specific assays. In 3-month placebo-controlled studies, treatment-emergent ADA responses were observed in 6 out of 1701 (0.4%) AJOVY-treated patients. One of the 6 patients developed anti-AJOVY neutralizing antibodies at Day 84. In the ongoing long-term open-label study, ADA were detected in 1.6% of patients (30 out of 1888). Out of 30 ADA-positive patients, 17 had a neutralizing activity in their post-dose samples. Although these data do not demonstrate an impact of antifremanezumab-vfrm antibody development on the efficacy or safety of AJOVY in these patients, the available data are too limited to make definitive conclusions. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary There are no adequate data on the developmental risk associated with the use of AJOVY in pregnant women. AJOVY has a long half-life. This should be taken into consideration for women who are pregnant or plan to become pregnant while using AJOVY. Administration of fremanezumab-vfrm to rats and rabbits during the period of organogenesis or to rats throughout pregnancy and lactation at doses resulting in plasma levels greater than those expected clinically did not result in adverse effects on development [see Animal Data]. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. The estimated rate of major birth defects (2.2-2.9%) and miscarriage (17%) among deliveries to women with migraine are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy. Data Animal Data When fremanezumab-vfrm (0, 50, 100, or 200 mg/kg) was administered to male and female rats by weekly subcutaneous injection prior to and during mating and continuing in females throughout organogenesis, no adverse embryofetal effects were observed. The highest dose tested was associated with plasma exposures (AUC) approximately 2 times that in humans at a dose of 675 mg. Administration of fremanezumab-vfrm (0, 10, 50, or 100 mg/kg) weekly by subcutaneous injection to pregnant rabbits throughout the period of organogenesis produced no adverse effects on embryofetal development. The highest dose tested was associated with plasma AUC approximately 3 times that in humans (675 mg). Administration of fremanezumab-vfrm (0, 50, 100, or 200 mg/kg) weekly by subcutaneous injection to female rats throughout pregnancy and lactation resulted in no adverse effects on pre- and postnatal development. The highest dose tested was associated with plasma AUC approximately 2 times that in humans (675 mg). 8.2 Lactation Risk Summary There are no data on the presence of fremanezumab-vfrm in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for AJOVY and any potential adverse effects on the breastfed infant from AJOVY or from the underlying maternal condition. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 Geriatric Use Clinical studies of AJOVY did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Manufactured by: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 US License No. 2016 ©2020 Teva Pharmaceuticals USA, Inc. This Brief Summary is based on the full Prescribing Information for AJOVY AJO-004.

FRE-42210

February 2020


DIAGNOSTIC AND DEVICE COMANPIES

DIRECTORIES

DIAGNOSTIC AND DEVICE companies —

A

Tarrytown, NY 10591 914-345-8300 www.aerolase.com

Abbott Hematology 4551 Great America Parkway Santa Clara CA 95054 408-982-4850 www.abbottdiagnostics. com

ALCOR Scientific Inc. 20 Thurber Blvd Smithfield, RI 02917 800-495-5270 www.alcorescientific.com

Abbott Point of Care 400 College Road East Princeton, NJ 08540 800-827-7828 www.pointofcare.abbott/ us/en/home

Abbott Toxicology 829 Towne Center Dr. Pomona, CA 91767 888-831-6850 https://www.aleretoxicology.com/home.html

Aerolase 777 Old Saw Mill River Road 12 | PHYSICIANS OFFICE RESOURCE

Alfa Wassermann 4 Henderson Drive West Caldwell, NJ 07006 800-220-4488 www.alfawassermannus. com Allscripts 222 Merchandise Mart Plaza, Suite 2024 Chicago, IL 60654 800-334-8534 www.allscripts.com AmazingCharts, Inc. 1600 Division Rd Suite 2000 West Warwuck, RI 02893 800-334-8534 www.amazingcharts.com

1-800-638-8663 www.bd.com American Academy of Family Physicians 11400 Tomahawk Creek Parkway Leawood, KS 66211-2672 800-274-2237 www.aafp.org American Screening Corporation 7607 Fern Ave #703 & 704 Shreveport, LA 71105 844-677-7639 www.americanscreeningcorp.com AMS Alliance 1790 N. Commerce Pkwy Weston, FL 33326 1 (954) 217-0040 www.amsdiagnostics.com Arkray 5198 W. 76th Street Edina, MN 55439 800-818-8877 www.arkrayusa.com B

BD Diagnostics 7 Loveton Circle Sparks, MD 21152

Beckman Coulter 250 South Kraemer Blvd Brea, CA 92821 800-526-3821 www.beckmancoulter.co

BioFire Diagnostics 515 Colorow Drive Salt Lake City, UT 84108 800-735-6544 www.biofiredx.com Bio-Rad Laboratories 2000 Alfred Nobel Drive Hercules, CA 94547 800-424-6723 www.bio-rad.com Bionix Development Corporation 5154 Enterprise Blvd. Toledo, OH 43612 800-551-7096 www.bionix.com


Bovie Medical Corporation 5115 Ulmerton Road Clearwater, FL 33760 800-537-2790 www.boviemedical.com

1060 Holland Dr., Suite A Boca Raton, FL 33487 877-722-6339 www.claritydiagnostics. com Clinical Diagnostics Solutions, Inc. 1800 NW 65th Avenue Plantation, FL 33313 954-791-1773 www.cdsolinc.com

The Brewer Company N88 W13901 Main Street, Suite 100 Menomonee Falls, WI 53051 888-273-9371 www.brewercompany.com Brilliant Medical Inc. P.O. Box 4456 Deerfield Beach, FL 33442 888-838-0432 www.brilliantmedical.com Brymill Cryogenic Systems 105 Windermere Avenue Ellington, CT 06029 860-875-2460 www.brymill.com C Cardiac Science N7 W22025 Johnson Drive Waukesha, WI 53186 855-366-0336 www.cardiacscience.com

Cepheid 904 Caribbean Drive Sunnyvale, CA 94089 888-838-3222 www.cepheid.com

Carolina Liquid Chemistries 313 Gallimore Dairy Rd Greensboro, NC 27409 877-722-8910 www.carolinachemistries. com Cerner Corporation 2800 Rockcreek Parkway North Kansas City, MO 64117 816-221-1024 www.cerner.com Clarity Diagnostics

Clinical Genomics 1031 US Highway 202/206, Suite 100 Bridgewater, NJ 08807 855-870-0096 www.clinicalgenomics.com COLA 9881 Broken Land Parkway Suite 200 Columbia, MD 21046-3016 800-981-9883 www.cola.org

CryoConcepts, LP 205 Webster Street Bethlehem, PA 18015 855-355-2796 Cryoconcepts.com Cutera, Inc. 3240 Bayshore Boulevard Brisbane, CA 94005 415-657-5500 www.cutera.com D The Daavlin Company 205 West Bement Street Bryan, OH 43506 800-322-8546 www.daavlin.com DermaMed Solutions, LLC 394 Parkmount Road P.O. Box 187 Lenni, PA 19052 610-358-4447 www.dermamedsolutions. com Detecto 203 East Daugherty Street Webb City, MO 64870 800-641-2008 www.detecto.com DRG International 841 Mountain Ave. Springfield, NJ 07081 973-564-7555 www.drg-international.com

Drucker Diagnostics 168 Bradford Drive Port Matilda, PA 16870 877-231-3115 www.druckerdiagnostics. com E

ELITechGroup North America 370 West 1700 South Logan, UT 84321 800-354-8324 www.elitechgroup.com Erba Diagnostics, Inc. 2140 North Miami Ave. Miami, FL 33127 800-327-4565 www.erbadiagnostics.com

Evoke Neuroscience 11 West 25th St., 10th Floor New York, NY 10010 917-261-6096 www.evokeneuroscience. com Exalenz Bioscience Inc. 35 Colby Avenue Suite 9 Manasquan, NJ 08736 1-888-392-5363 www.exalenz.com

Exergen Corporation 400 Pleasant St. Watertown, MA 02472 1-800-422-3006 www.exergen.com F FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021-3904 877-657-8118 www.sonosite.com

877.932.6301 www.greenwayhealth.com H H&O Equipments Inc. 4055 Faber Place Dr. North Charleston, SC 29405 888-248-2838 www.ho-equipments.com Heine North America 10 Innovation Way Dover, NH 03820 800-367-4872 www.heine.com Helena Laboratories 1530 Lindbergh Drive Beaumont, TX 77707 800-231-5663 www.helena.com Hemocue 250 South Kraemer Blvd. Mailstop: B1.SW.11 Brea, CA 92821 800-881-1611 www.hemocue.us www.hemocue.us

Hemosure, Inc. 5358 Irwindale Ave., Unit A Irwindale, CA 91706 888-436-6787 www.hemosure.com Hologic, Inc. 250 Campus Drive Marlborough, MA 01752 508-263-2900 www.hologic.com

Horiba Medical 9755 Research Dr. Irvine, CA 92618 888- 903-5001 www.horiba.com/us/en/ medical

Futuremed 15700 Devonshire Street Granada Hills, CA 91344 800-222-6780 www.futuremed.com

Huntleigh Diagnostics 35 Portmanmoor Road Cardiff CF24 5HN Wales UK 800-323-1245 www.huntleigh-diagnostics.com

G Greenway Health, LLC. 100 Greenway Blvd Carrollton, GA 30117

I Interson Corporation 7150 Koll Center Parkway Pleasanton, CA 94566 2021 · BUYERS GUIDE | 13


DIAGNOSTIC AND DEVICE COMANPIES

DIRECTORIES

925-462-4948 www.interson.com iSalus Healthcare 1 Virginia Avenue Suite 500 Indianapolis, IN 46204 888-280-6678 www.isalushealthcare.com

M

Masimo 52 Discovery Irvine, CA 92618 800-326-4890 www.masimo.com

J

Jant Pharmacal 16530 Ventura Blvd., Suite 512 Encino, CA 91436 800-676-5565 www.jantdx.com Jones Medical Instrument Company 200 Windsor Drive Oak Brook, IL 60523 800-323-7336 www.jonesmedical.com K

Korr Medical Technologies, Inc. 3487 W 2100 S, Building 300 Salt Lake City, UT 84119 800-895-4048 www.korr.com L

Laboratory Consulting, LLC 1835 Hwy 45 N #315 Columbus, MS 39705 800-673-9251 www.onlinelabhelp.com

LifeSign 85 Orchard Road Skillman, NJ 08558 800-526-2125 www.lifesignmed.com

14 | PHYSICIANS OFFICE RESOURCE

Medica Corporation 5 Oak Park Drive Bedford, MA 01730 800-777-5983 www.medicacorp.com Medical Acoustics, LLC 640 Ellicott Street, 4th Floor Buffalo, NY 14203 888-820-0970 www.lungflute.com

Medical Device Depot 3230 Bethany Lane, Suite 8 Ellicott City, MD 21042 877-646-3300 www.medicaldevicedepot. com Meridian Bioscience 3471 River Hills Drive Cincinnati, OH 45244 978-856-2345 www.magellandx.com MIR - Medical International Research 5462 S. Westridge Drive New Berlin, WI 53151 262-565-6797 www.spirometry.com

Medicus LIS 4555 NW 103rd Avenue Suite 105 Sunrise, FL 33351 888-643-8081 www.medicuslis.com

Medpod 1460 Broadway New York, NY 10036 844-633-7631 www.medpodhealth.com

MedTest 5449 Research Drive Canton, MI 48188 800-445-9853 www.medtest.com Mercedes Medical 7590 Commerce Court Sarasota, FL 34243 800-331-2716 www.mercedesmedical. com

Micro Direct 803 Webster St. Lewiston, ME 04240 800-588-3381 www.mdspiro.com Midmark 1700 S. Patterson Blvd., Suite 400 Dayton, Ohio 45409 800-643-6275 www.midmark.com Mindray USA Corp. 800 MacArthur Blvd. Mahwah, NJ 07430 800-288-2121 www.mindraynorthamerica. com

My Inspection 4555 NW 103rd Avenue Suite 105 Sunrise, FL 33351 888-643-8081 www.myinspection.us N NanoEnTek 240 Bear Hill Road, Suite 101 Waltham, MA 02451 781-472-2558 www.nanoentek.com Nasiff Associates, Inc. 841 County Route 37, Suite 1 Central Square, NY 13036 866-627-4332 www.nasiff.com ndd Medical Technologies 300 Brickstone Square Suite 604 Andover, MA 01810

978-470-0923 www.nddmed.com NeuroMetrix, Inc. 1000 Winter Street Waltham, MA 02451 Phone (888) 786 7287 www.neurometrix.com Newman Medical 5350 Vivian St., Unit C Arvada, CO 80002 800-267-5549 www.newman-medical.com Nihon Kohden 90 Icon Street Foothill Ranch, CA 92610 800-325-0283 www.nihonkohden.com Nonin Medical 13700 1st Avenue North Plymouth, MN 55441 800-356-8874 www.nonin.com Nova Biomedical 200 Prospect Street Waltham, MA 02545 781-894-0800 www.novabio.us O Opti Medical, Inc. 235 Hembree Park Drive Rosewell, GA 30076 800-490-6784 www.optimedical.com

OraSure Technologies, Inc. 220 East First Street Bethlehem, PA 18015 800-869-3538 www.orasure.com Ortho Clinical Diagnostics 1001 Route 202 Raritan, NJ 08869 800-828-6316 www.orthoclinical.com Ototronix 5000 Township Parkway Saint Paul, MN 55110 855-696-2986 www.ototronix.com Owen Mumford, Inc. 1755 West Oak Commons Court Marietta, GA 30062 770- 977- 2226 www.owenmumford.com/ us/


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DIAGNOSTIC AND DEVICE COMANPIES

DIRECTORIES

P pts Diagnostics 7736 Zionsville Road Indianapolis, IN 46268 877-870-5610 www.ptsdiagnostics.com Phreesia 432 Park Ave. South, 12th Floor New York, NY 10016 888-654-7473 www.phreesia.com

Physicians Office Resource A Division of Medical Education Resources, LLC 43 Golden Drive Bedford, NH 03110 603-472-9001 www.physiciansofficeresource.com Polestar Labs, Inc. 1223 Pacific Oaks Place, Ste. 102 Escondido, CA 92029 800-836-4848 www.polestarlabs.com Polymedco, Inc. 510 Furnace Dock Road Cortlandt Manor, NY 10567 800-431-2123 www.polymedco.com Premier Medical 1710 Romano Drive Plymouth Meeting, PA 19462 888-670-6100 www.premiermedicalco. com Q Quest Diagnostics 500 Plaza Drive Secaucus, NJ 07094 973-520-2700 www.questdiagnostics.com Quidel 12544 High Bluff Dr., Suite 200 San Diego, CA 92130 858.552.1100 www.quidel.com R Radiometer America, Inc. 250 S. Kraemer Blvd. Brea, CA 92821 800-736-0600 www.radiometeramerica. com

16 | PHYSICIANS OFFICE RESOURCE

Randox Laboratories LTD. 55 Diamond Road, Crumlin, County Antrim United Kingdom, BT29 4QY 866-472-6369 www.randox.com Resmed Corporation 9001 Spectrum Center Blvd. San Diego, CA 92123 800-424-0737 www.resmed.com Roche Diagnostics Corp. 9115 Hague Road Indianapolis, IN 46250 800.428.5074 www.roche-diagnostics.us S Schiller America, Inc. 10903 NW 33rd St. Doral, FL 33172 786-845-0620 www.schiller.ch/us SDI Diagnostics Ten Hampden Drive Easton, MA 02375 800-678-5782 www.sdidiagnostics.com

Sekisui Diagnostics 4 Hartwell Place Lexington, MA 02421 781-652-7800 www.sekisuidiagnostics. com Sempermed USA 13900 49th St. North Clearwater, FL 33762 727-787-7250 www.sempermedusa.com SHL Telemedicine USA 90 Yigal Alon St. Tel Aviv 67891 Israel 972-3-5612212 www.shl-telemedicine.com

Siemens Healthcare Diagnostics 511 Benedict Avenue Tarrytown, NY 10591-5097 800-743-6367 www.usa.siemens.com Smiths Medical 5200 Upper Metro Place, Suite 200 Dublin, OH 43017 800-258-5361 www.smiths-medical.com Stanbio Laboratory 1261 North Main Street Boerne, TX 78006 800-531-5535 www.ekfusa.com Streck Labs 7002 S. 109th St. La Vista, NE 68128 800-228-6090 www.streck.com Syneron-Candela 3 Goodyear, Unit A Irvine, CA 92618 866-259-6661 www.syneron-candela.com

Sysmex America, Inc. 577 Aptakisic Rd. Lincolnshire, IL 60069 866-779-7639 www.sysmex.com/us T Tanita Corporation of America, Inc. 2625 South Clearbrook Drive Arlington Heights, IL 60005 847-640-9241 www.tanita.com Thermo Fisher Scientific 168 Third Avenue Waltham, MA 02451 800-678-5599 www.thermofisher.com Tosoh Bioscience 6000 Shoreline Court, Suite 101 South San Francisco, CA 94080 800-248-6764 www.diagnostics.us.tosohbioscience.com

Trinity Biotech 2823 Girts Rd. Jamestown, NY 14701 800-325-3424 www.trinitybiotech.com Tuttnauer USA Co. 25 Power Drive Hauppauge, NY 11788 800-624-5836 www.tuttnauerusa.com V Vinyl Crafters 47 West Frederick Street Walkersville, MD 21793 800-286-8738 www.vcupholstery.com

Vitalograph 13310 W. 99th St. Lenexa, KS 66215 800-255-6626 www.vitalograph.com W Wallach Surgical 95 Corporate Dr. Trumbull, CT 06611 800-243-2463 www.wallachsurgical.com

Welch Allyn 4341 State Street Road Skaneateles Falls, NY 13153 800-535-6663 www.welchallyn.com Z Zanfel Laboratories, Inc. 1370 Northwest 114th St. #204 Clive, IA 50325 800-401-4002 www.zanfel.com


Solid & Glass Door Refrigerators From 1 to 15 Cu.ft.

Refrigerators & Freezers From 23 to 49 Cu.ft. Refrigeration designed and purpose-built for pharmacy, medication, and vaccination applications to support meeting CDC/VFC vaccine storage guidelines

+/-1ÂşC variation derived from the maximum deviation of an NTC sensor in a 1 oz. vial located nearest the champer geometric center during a 24 hour test period

Advanced Temperature Control & Durable Performance

• Intelligent microprocessor digital temperature controller • Adjustable operating control range from +2 to +8ºC • Digital display of the min/max temperature in Celsius or Fahrenheit • Password protected control parameters beyond setpoitn • Optimized forced air cooling for excellent stability & uniformity with rapid recovery • Open door and high/low temperature alarms • Factory installed lock conveniently located towards the top of each unit • $GMXVWDEOH VKHOYLQJ FDQ EH VSDFHG LQ ó¾ LQWHUYDOV IRU IOH[LEOH VWRUDJH

Pharma-Vac Refrigerators Accucold ARS1PV ARG1PV ARS3PV ARG3PV ARS6PV ARG6PV ARS8PV ARG8PV ARS12PV ARG12PV ARS15PV ARG15PV

Capacity 1 cu.ft. 1 cu.ft. 3 cu.ft. 3 cu.ft. 6 cu.ft. 6 cu.ft. 8 cu.ft. 8 cu.ft. 12 cu.ft. 12 cu.ft. 15 cu.ft. 15 cu.ft.

790*,

Height 21.5� 21.5� 33.75� 33.75� 32.5� 32.5� 50� 50� 61.75� 61.75� 72� 72�

Width 17.5� 17.5� 18.5� 18.5� 23.5� 23.5� 23.38� 23.38� 23.38� 23.38� 23.5� 23.5�

Depth 19.5� 20� 19� 19.5� 24.5� 25� 24.5� 25� 24.5� 25� 24.5� 25�

Door White Glass White Glass White Glass White Glass White Glass White Glass

Height 83.75 83.75 83.75 83.75

Width 27.5 27.5 55.25 55.25

Depth 31 31 31 31

Door (1) Stainless (1) Glass (2) Stainless (2) Glass

790*,

Height 83.75 83.75

Width 27.5 55.25

Depth 31 31

Door (1) Stainless (2) Stainless

790*,

Pharma-Lab Refrigerators Accucold ARS23ML ARG23ML ARS49ML ARG49ML

Capacity 23 cu.ft. 23 cu.ft. 49 cu.ft. 49 cu.ft.

Pharma-Lab Freezers Accucold AFS23ML AFS49ML

Capacity 23 cu.ft. 49 cu.ft.

Choosing the Right Sized Unit Below are a few handy steps for determining the ideal Accucold refrigerator size for your clinic:

1

Estimate the maximum number of doses of publicly-provided vaccine and privately purchased vaccine that will be in your refrigerator.

Refrigerator: Public Vaccine

Add the number of doses on hand (current inventory) from your last order form. ________________

2

Match your maximum doses with the minimum cubic feet needed to safely store your vaccine

Max. Doses

Minimum Cubic Ft.

2,000+ doses

may need more than one refrigerator

1000-2000

40 cu.ft

Private Vaccine

+ ________________

900-1000 801-900

36 cu.ft 21-23 cu.ft

Total doses

= ________________

701-800

17-19.5 cu.ft

Multiply (max inventory) Maximum doses

x 1.25 = ________________

400-700

11-16.7 cu.ft

100-399

4.9-6.1 cu.ft

8706


ASSESSING AND MONITORING COVID-19 PATIENTS. Urgent care facilities, primary care practices, and other outpatient settings at the front lines of the COVID-19 pandemic need on-site testing solutions to support patient assessment and monitoring. With-patient testing can lead to better healthcare performance by facilitating decisions that can optimize patient outcomes in real time, improving the quality of patient care.

8707

For facilities treating COVID-19 patients, having rapid, accurate diagnostic test results may be useful when assessing or monitoring patients for: • C-Reactive Protein (CRP) Levels may be elevated in COVID-19 cases, especially severe cases.2-15 • Liver, Kidney and Cardiac function Elevated levels of the following biomarkers may be indicators of COVID-19 severity:16-27 - Alanine Aminotransferase (ALT)16,17,20-27 - Albumin (ALB)16,19-22,25-27 - Aspartate Aminotransferase (AST)16,17,19-21,23-26 - Creatine Kinase (CK)16,18,20,22-24 - Creatinine (CREAT)16,22,23,25,27 - Total Bilirubin (TBILI)16,20,25,27

ON-SITE TESTING MADE EASY: PICCOLO XPRESS.® The Piccolo Xpress portable diagnostic analyzer offers a full complement of blood chemistry tests, including CLIA-waived tests. Get accurate results in minutes, at the point-of-care. SEE A LIST OF KEY PICCOLO XPRESS PANELS ON BACK.

For in vitro diagnostic use only. The Piccolo Xpress does not directly diagnose COVID-19.


KEY PICCOLO XPRESS PANELS. CLIA-WAIVED PANELS

MODERATELY COMPLEX PANELS

Comprehensive Metabolic Panel

BioChemistry Panel Plus

Na+, K+, CI-, tCO2, Ca, BUN, Crea, Glu,

ALB, ALP, ALT, AMY, AST, BUN, Ca,

ALB, ALP, ALT, AST, TP, tBIL, eGFR*

Crea, Glu, GGT, TP, UA, CRP, eGFR*

MetLyte 8

MetLyte Plus CRP

Na+, K+, Cl-, tCO2, BUN, Crea, Glu,

Na+, K+, Cl-, tCO2, BUN, Crea, Glu,

CK, eGFR*

CK, CRP, eGFR*

Liver Panel Plus

Hepatic Function Panel

ALB, ALP, ALT, AMY, AST, GGT,

ALB, ALP, ALT, AST, tBIL, dBIL, TP

tBIL, TP

*Calculated

To learn how the Piccolo Xpress portable diagnostic analyzer can help transform your patient care, contact your Abbott Point of Care Representative or visit www.pointofcare.abbott 1.

2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14.

The Governing Board The American Association for the Study of Liver Diseases, Released: April 7, 2020. CLINICAL INSIGHTS FOR HEPATOLOGY AND LIVER TRANSPLANT PROVIDERS DURING THE COVID-19 PANDEMIC. Guan WJ et al. medRxiv preprint 2020; doi: https://doi.org/10. 1101/2020.02.06.20020974 Chen N et al. Lancet 2020; 395: 507–13 ; https://doi. org/10.1016/S0140-6736(20)30211-7 Cao W et al. medRxiv preprint 2020; doi: https://doi. org/10.1101/2020.02.23.20026963 Shi H et al. Lancet Infect Dis 2020 ; https://doi.org/10.1016/ S1473-3099(20)30086-4 Shi S et al. Jama Cardiology 2020; published online March 25; doi:10.1001/jamacardio.2020.0950 Xu H et al. medRxiv preprint 2020; doi: https://doi. org/10.1101/2020.03.05.20031591 Young BE et al. JAMA. Published online March 3, 2020; doi:10.1001/jama.2020.3204 Ruan Q et al. Intensive Care Medicine 2020. https://doi. org/10.1007/s00134-020-05991-x Zhou B. Research Square 2020; DOI:10.21203/rs.3.rs-18079/v1 Zhou S et al. AJR 2020; 215:1-8; doi.org/10.2214/AJR.20.22975 Li J et al. medRxiv preprint 2020; doi: https://doi. org/10.1101/2020.02.11.20022053 Deng SQ, Peng HJ. J. Clin. Med. 2020; 9, 575 (Review); doi:10.3390/jcm9020575 Ständiger Arbeitskreis der Kompetenz- und Behandlungszentren für Krankheiten durch hochpathogene Erreger am Robert Koch-Institut (STAKOB). Hinweise zu Erkennung, Diagnostik

15.

16.

17. 18.

19.

20.

21.

und Therapie von Patienten mit COVID-19; Downloaded 13. March 2020; www.rki.de/covid-19-therapie Chinese CoVID Management Guidelines-19, Version 7; published on 3/3/2020 by R.P.C. National Health Commission and the National Administration of Traditional Medicine of R.P.C.; translated by Jinwei Sun, Physician Specializing in Cardiovascular Disorders at the University of Milan-Bicocca Henry et al. 2020 Apr 10 Clinical Chemistry and Laboratory Medicine. Hematologic, biochemical and immune biomarker abnormalities associated with severe illness and mortality in coronavirus disease 2019 PMID: 32286245 DOI: 10.1515/cclm2020-0369. Ferrari et al. 2020 Apr 16 Clinical Chemistry and Laboratory Medicine. Routine blood tests as a potential diagnostic tool for COVID-19 PMID: 3230176 DOI: 10.1515/cclm-2020-0398. Yuan et al. 2020 Mar 29 Inflammation Research. The correlation between viral clearance and biochemical outcomes of 94 COVID-19 infected discharged patients PMID: 32227274 DOI: 10.1007/s00011-020-013242-0. Huang et al. 2020 Feb 15 The Lancet. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China PMID: 31986264 PMCID: PMC7159299 DOI: 10.1016/ S0140-6736(20) 30183-5. Chen et al. 2020 Feb 15 The Lancet. Epidemiological and clinical characteristics of 99 cases of 2019 novel coronavirus pneumonia in Wuhan, China: a descriptive study PMID: 32007143 PMCID: PMC7135076 DOI: 10.1016/S0140-6736(20)30211-7. The Governing Board The American Association for the Study of Liver Diseases, Released: April 7, 2020. CLINICAL IN

POINT OF CARE ©Abbott Point of Care Inc. 400 College Road East, Princeton, NJ 08540 (609) 454-9000 (609) 419-9370 (fax) www.pointofcare.abbott For in vitro diagnostic use only.

I

This material is intended for a U.S. audience only.

COVID-19 Channel Brochure - US 2994Rev.1 09/20 Piccolo Xpress is a registered trademark of Abaxis, Inc. and distributed by Abbott Point of Care. Abaxis 888-3354 Rev A

22.

23.

24.

25.

26.

27.

SIGHTS FOR HEPATOLOGY AND LIVER TRANSPLANT PROVIDERS DURING THE COVID-19 PANDEMIC. Zhou et al. 2020 Mar 28 The Lancet. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study PMID 32171076 DOI: 10.1016/S0140-6736(20) 30566-3. Guan et al. 2020 Apr 30 The New England Journal of Medicine. The Clinical Characteristics of Coronavirus Disease 2019 in China PMID: 32109013 PMCID: PMC7092819 DOI: 10.1056/NEJMoa2002032. Holshue et al and The Washington State 2019-nCoV Case Investigation Team 2020 Mar 5 The New England Journal of Medicine Case Reports. First Case of 2019 Novel Coronavirus in the United States PMID: 32004427 PMCID: PMC7092802 DOI: 10.1056/NEJMoa2001191. Wu et al. 2020 Mar 13 JAMA Internal Medicine. Risk Factors Associated With Acute Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease 2019 Pneumonia in Wuhan, China PMID: 32167524 PMCID: PMC7070509 DOI: 10.1001/jamainternmed.2020.0994. Chen et al. 2020 May 1 The Journal of Clinical Investigation. Clinical and immunological features of severe and moderate coronavirus disease 2019 PMID: 32217835 PMCID: PMC7190990 (available on 2020-08-01) DOI: 10.1172/ JCI137244. Wang et al. 2020 Apr 23 The Journal of Clinical Investigation Insight. The laboratory tests and host immunity of COVID-19 patients with different severity of illness PMID: 32324595 DOI: 10.1172/jci.insight.137799.


DIRECTORIES HEALTH AGENCY HOTLINES

HEALTH AGENCY hotlines —

Adoption National Adoption Center www.adopt.org (800) 862-3678 Aging National Aging Info and Referral Support Center www.nasuad.org (202) 898-2578 Alcohol Abuse Al-Anon Family Groups www.al-anon.alateen. org (757) 563-1600 Allergy/Asthma American Academy of Allergy, Asthma & Immunology www.aaaai.org (414) 272-6071

Anemia Aplastic Anemia & MDS International Foundation www.aamds.org (800) 747-2820 Sickle Cell Disease Association of America, Inc. www.sicklecelldisease. org (800) 421-8453 Arthritis Arthritis Foundation Info Hotline www.arthritis.org (844) 571-4357 Bladder Diseases Interstitial Cystitis Association www.ichelp.org (703) 442-2070

FARE/ Food Allergy Research & Education www.foodallergy.org (800) 929-4040

Blood Disorders National Hemophilia Foundation www.hemophilia.org (212) 328-3700

Alzheimer’s Disease Alzheimer’s Association www.alz.org (800) 272-3900

Bone Marrow National Bone Marrow Transplant Link www.nbmtlink.org (800) 546-5268

20 | PHYSICIANS OFFICE RESOURCE

Bone Disease National Institute of Arthritis & Musculoskeletal & Skin Diseases www.niams.nih.gov (877) 226-4267 Breast Disease National Breast & Cervical Cancer Early Detection Program www.cdc.gov/cancer/ nbccedp (800) 232-4636 Digestive Disorders/ Diseases Crohn’s & Colitis Foundation of America www.ccfa.org (800) 932-2423 Celiac Disease Foundation www.celiac.org (818) 716-1513 Eating Disorders National Eating Disorders Association www.nationaleatingdisorders.org (800) 931-2237

Eye Disease American Macular Degeneration Foundation www.macular.org (888) 622-8527 The Vision Council www.thevisioncouncil. org (866) 826-0290 Glaucoma Research Foundation www.glaucoma.org (415) 986-3162 Fibromyalgia National Fibromyalgia Association www.fmaware.org Gastrointestinal Diseases International Foundation for Functional Gastrointestinal Disorders www.iffgd.org (414) 964-1799 Growth Disorders Human Growth Foundation www.hgfound.org (800) 451-6434


Hearing Disorders International Hearing Society www.ihsinfo.org (734) 522-7200 Heart Disease American Heart Association www.heart.org (800) 242-8721 Hepatitis C Hepatitis C Association www.hepcassoc.org (908) 769-8479 Hospital/Hospice Care Caring Connections www.caringinfo.org (703) 837-1500 Immunization National Immunization Hotline www.cdc.gov/vaccines (800) 232-4636 Impotence American Urological Association www.auanet.org (866) 746-4282 Insurance/Medicare/ Medicaid Medicare Issues Hotline www.medicare.gov (800) 633-4227 Kidney Disease National Kidney Foundation www.kidney.org (800) 622-9010 Lead EPA Lead Information Center www.epa.gov/lead (800) 424-5323

Liver Diseases American Liver Foundation www.liverfoundation. org (212) 668-1000 Lung Disease/Asthma/ Allergy American Lung Association www.lungusa.org (800) 586-4872

Paralysis and Spinal Injury Christopher & Dana Reeve Foundation www.christopherreeve. org (800) 539-7309 Parkinson’s Disease Parkinson’s Disease Foundation www.parkinson.org (800) 473-4636

Mental Health Mental Health America www.mentalhealthamerica.net (800) 969-6642

Pediatrics American Academy of Pediatrics www.aap.org (800) 433-9016

Minority Health US Department of Health and Human Services Office of Minority Health www.minorityhealth. hhs.gov (800) 444-6472

Poison Control American Association of Poison Control Centers www.aapcc.org (800) 222-1222

Nervous System Disease American Parkinson Disease Association www.apdaparkinson. org (800) 223-2732 Multiple Sclerosis Foundation www.msfocus.org (888) 673-6287 National Stroke Association www.stroke.org (800) 242-8721 Organ Donation Living Bank www.livingbank.org (800) 528-2971 Pancreatic Disease Pancreatic Cancer Action Network www.pancan.org (877) 573-9971

Professionals American Medical Association www.ama-assn.org (800) 622-3211 Rehabilitation National Rehabilitation Info. Ctr. www.naric.com (800) 346-2742 Rheumatic Diseases Scleroderma Foundation www.scleroderma.org (800) 722-4673 Sexually Transmitted Diseases CDC Sexually Transmitted Diseases Info. www.cdc.gov/std/ (800) 232-4636

Spinal Diseases National Scoliosis Foundation, Inc. www.scoliosis.org (800 )673-6922 Stroke National Stroke Association www.stroke.org (800) 242-8721 Sudden Infant Death Syndrome American SIDS Institute www.sids.org (239) 431-5425 Surgery/Facial Plastic Surgery American Society of Plastic Surgeons www.plasticsurgery.org (847) 228-9900 Thyroid Disease American Thyroid Association www.thyroid.org (703) 998-8890 Veterans Veterans Special Issue Helpline Department ofVeterans Affairs www.va.gov (844) 698-2311 VA Suicide Prevention www.mentalhealth. va.gov (844) 698-2311 Vision Disorders American Council of the Blind www.acb.org (800) 424-8666

Skin Disease National Psoriasis Foundation www.psoriasis.org (800) 723-9166 2021 · BUYERS GUIDE | 21


A breakthrough for patients with advanced CSCC1 LIBTAYO® is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.1 For patients with mCSCC or laCSCC receiving 3 mg/kg every 2 weeks in Study 1540:

46% ORR

31% PR (partial response)†

15% CR

(complete response)‡ (objective response rate)*

ORR: 63 out of 137 patients (95% CI, 37%-55%)1,2

79% of responders (50 out of 63 patients) reached a DOR of ≥6 months1,2* 54% of responders (34 out of 63 patients) reached a DOR of ≥12 months1,2* Median DOR was not reached (range: 1.9–24.2+ months)1-3* *Median duration of follow-up was 11.1 months for combined CSCC in Study 1540.1 See additional study design details below.

In an additional cohort in Study 1540, 56 mCSCC patients received LIBTAYO at a dose of 350 mg intravenously every 3 weeks for up to 54 weeks. With a median duration of follow-up of 8.0 months, the confirmed ORR was 41% (95% CI: 28, 55), and 65% of responders had a DOR ≥6 months.1 Median DOR was not reached (range: 2.1–11.1+ months)2 Plus sign (+) denotes ongoing at last assessment.

• Study 1540—EMPOWER-CSCC 1—was a global, pivotal, open-label, nonrandomized, multicohort study that included a total of 193 patients with mCSCC or laCSCC who were not candidates for curative surgery or curative radiation.1,2,4 Patients received LIBTAYO 3 mg/kg intravenously every 2 weeks for up to 96 weeks or 350 mg LIBTAYO every 3 weeks for up to 54 weeks.1,3 Treatment continued until progression of disease, unacceptable toxicity, or completion of planned treatment.1 The cutoff for Study 1540 data in the USPI is September/October 20182

• The major efficacy outcome measures were confirmed ORR, defined as CR plus PR as assessed by independent central review (ICR), and ICR-assessed DOR1 • Study 1540 excluded patients with autoimmune disease who required systemic therapy with immunosuppressant agents within 5 years; history of solid organ transplant; prior treatment with anti–PD-1/programmed death ligand 1 (PD-L1) blocking antibodies or other immune checkpoint inhibitor therapy; infection with HIV, hepatitis B, or hepatitis C; or ECOG PS ≥21

The recommended dosage of LIBTAYO is 350 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression or unacceptable toxicity.1 Partial response is defined as a decrease of 30% or greater in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters, per RECIST 1.1. Partial response of externally visible disease is defined as a decrease of 50% or greater in the sum of products of perpendicular longest diameters of target lesions, per WHO Criteria. Nontarget lesions could not have progressive disease, and there could be no new lesions. Responses had to be maintained for at least 4 weeks.2 ‡ Complete response is defined as disappearance of all target lesions for at least 4 weeks. Nontarget lesions also had to be a complete response, and there could be no new lesions. Any pathological lymph nodes (whether target or nontarget ) must have reduction in short axis to <10 mm (<1 cm). Only includes patients with complete healing of prior cutaneous involvement; patients with laCSCC in Study 1540 required biopsy to confirm CR.1,2

†

Important Safety Information Warnings and Precautions

Severe and Fatal Immune-Mediated Adverse Reactions Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue and usually occur during treatment; however, they can also occur after discontinuation. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously. Early identification and management are essential to ensuring safe use of PD-1–blocking antibodies. Monitor for symptoms and signs of immune-mediated adverse reactions. Evaluate clinical chemistries, including liver tests and thyroid function tests, at baseline and periodically during treatment. Institute medical management promptly to include specialty consultation as appropriate. In general, withhold LIBTAYO for Grade 3 or 4 and certain Grade 2 immune-mediated adverse reactions. Permanently discontinue LIBTAYO for Grade 4 and certain Grade 3 immune-mediated adverse reactions. For Grade 3 or 4 and certain Grade 2 immune-mediated adverse reactions, administer corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) or other appropriate therapy until improvement to Grade 1 or less followed by a corticosteroid taper over 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroids. Institute hormone replacement therapy for endocrinopathies as warranted. Immune-mediated pneumonitis: Immune-mediated pneumonitis occurred in 2.4% of 534 patients receiving LIBTAYO, including Grade 5 (0.2%), Grade 3 (0.7%), and Grade 2 (1.3%). Pneumonitis led to permanent discontinuation of LIBTAYO in 1.3% of patients. Systemic corticosteroids were required in all patients with pneumonitis, including 85% who received prednisone ≥40 mg/day or equivalent. Pneumonitis resolved in 62% of patients. Withhold LIBTAYO for Grade 2, and permanently discontinue for Grade 3 or 4. Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper.

Immune-mediated colitis: Immune-mediated colitis occurred in 0.9% of 534 patients receiving LIBTAYO, including Grade 3 (0.4%) and Grade 2 (0.6%). Colitis led to permanent discontinuation of LIBTAYO in 0.2% of patients. Systemic corticosteroids were required in all patients with colitis, including 60% who received prednisone ≥40 mg/day or equivalent. Colitis resolved in 80% of patients. Withhold LIBTAYO for Grade 2 or 3, and permanently discontinue for Grade 4. Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Immune-mediated hepatitis: Immune-mediated hepatitis occurred in 2.1% of 534 patients receiving LIBTAYO, including Grade 5 (0.2%), Grade 4 (0.2%), and Grade 3 (1.7%). Hepatitis led to permanent discontinuation of LIBTAYO in 0.9% of patients. Systemic corticosteroids were required in all patients with hepatitis, including 91% who received prednisone ≥40 mg/ day or equivalent. Hepatitis resolved in 64% of patients. Withhold LIBTAYO if AST or ALT increases to more than 3 and up to 10 times the upper limit of normal (ULN) or if total bilirubin increases up to 3 times the ULN. Permanently discontinue LIBTAYO if AST or ALT increases to more than 10 times the ULN or total bilirubin increases to more than 3 times the ULN. Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Immune-mediated endocrinopathies: Withhold LIBTAYO if clinically necessary for Grade 2, 3, or 4. • Adrenal insufficiency: Adrenal insufficiency occurred in 0.4% of 534 patients receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2 (0.2%) • Hypophysitis: Hypophysitis, which can result in hypopituitarism, occurred in 0.2% of 534 patients receiving LIBTAYO, which consisted of 1 patient with Grade 3 hypophysitis • Hypothyroidism: Hypothyroidism occurred in 6% of 534 patients receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2 (5.6%); no patients discontinued hormone replacement therapy

Please see additional Important Safety Information and Brief Summary of full Prescribing Information on the following pages.


LIBTAYO® (cemiplimab-rwlc) demonstrated meaningful tumor reduction in clinical trial patients1,2 Partial responses These are examples from the 31% of patients who had a partial response in clinical trials. Individual patient responses may vary.

Locally advanced CSCC Not a candidate for curative surgery or curative radiation

Metastatic CSCC

History • 70-year-old male • Auricular lesions†

Outcomes* • Best overall response: PR per composite (RECIST 1.1 + WHO Criteria) evaluation by ICR • Best percent change in target lesion(s): 91.9% per WHO Criteria

History • 66-year-old male • Periclavicular lesions

Screening

After 16 weeks

Screening

After 32 weeks

Outcomes* • Best response: PR per composite (RECIST 1.1 + WHO Criteria) evaluation by ICR • Best percent change in target lesion(s): 71.1% per RECIST 1.1

After 24 weeks

*Results as of data cutoff October 27, 2017.2 † This patient also had cranial lesions that were included in the calculation of best percent change in target lesion(s). Those images are not included here.2 DOR=duration of response; ECOG=Eastern Cooperative Oncology Group; ICR=independent central review; PS=performance status; Q2W=every 2 weeks; Q3W=every 3 weeks; RECIST=Response Evaluation Criteria in Solid Tumors; WHO=World Health Organization.

After 48 weeks

See more patient profiles at LIBTAYOhcp.com.

Important Safety Information (continued) Warnings and Precautions (continued) Severe and Fatal Immune-Mediated Adverse Reactions Immune-mediated endocrinopathies (continued): • Hyperthyroidism: Hyperthyroidism occurred in 1.5% of 534 patients receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2 (0.4%); hyperthyroidism resolved in 38% of patients • Type 1 diabetes mellitus: Type 1 diabetes mellitus, which can present with diabetic ketoacidosis, occurred in 0.7% of 534 patients, including Grade 4 (0.4%) and Grade 3 (0.4%); type 1 diabetes mellitus led to permanent discontinuation of LIBTAYO in 0.2% of patients Immune-mediated nephritis with renal dysfunction: Immune-mediated nephritis occurred in 0.6% of 534 patients receiving LIBTAYO, including Grade 3 (0.4%) and Grade 2 (0.2%). Nephritis led to permanent discontinuation of LIBTAYO in 0.2% of patients. Systemic corticosteroids were required in all patients with nephritis, including 67% who received prednisone ≥40 mg/day or equivalent. Nephritis resolved in all patients. Withhold LIBTAYO for Grade 3, and permanently discontinue for Grade 4. Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Immune-mediated dermatologic adverse reactions: Immune-mediated dermatologic reactions, including erythema multiforme and pemphigoid, occurred in 1.7% of 534 patients receiving LIBTAYO, including Grade 3 (1.1%) and Grade 2 (0.6%). In addition, Stevens-Johnson Syndrome (SJS) and toxic epidermal necrolysis (TEN) have been observed with LIBTAYO and with other products in this class. Systemic corticosteroids were required in all patients with dermatologic reactions, including 89% who received prednisone ≥40 mg/day or equivalent. Dermatologic reactions resolved in 33% of patients. Approximately 22% of patients had recurrence of dermatologic reactions after re-initiation of LIBTAYO. Withhold LIBTAYO for Grade 3, and permanently discontinue for Grade 4. Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. Other immune-mediated adverse reactions: The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% in 534 patients who received LIBTAYO or were reported with the use of other PD-1–blocking and PD-L1–blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions. Withhold LIBTAYO for Grade 3, and permanently discontinue for Grade 4. Resume in patients with complete or partial resolution (Grade 0 to 1) after corticosteroid taper. • Neurological: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/ myasthenia gravis, Guillain-Barré syndrome, nerve paresis, and autoimmune neuropathy • Cardiovascular: Myocarditis, pericarditis, and vasculitides • Ocular: Uveitis, iritis, and other ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various Grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada–like syndrome, as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss • Gastrointestinal: Pancreatitis to include increases in serum amylase and lipase levels, gastritis, and duodenitis • Musculoskeletal and connective tissue: Myositis, rhabdomyolysis, and associated sequelae, including renal failure, arthritis, and polymyalgia rheumatica • Hematological and immunological: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, and solid organ transplant rejection

Infusion-related reactions Severe infusion-related reactions (Grade 3) occurred in 0.2% of patients receiving LIBTAYO. Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion for Grade 1 or 2, and permanently discontinue for Grade 3 or 4.

Embryo-fetal toxicity LIBTAYO can cause fetal harm when administered to a pregnant woman due to an increased risk of immune-mediated rejection of the developing fetus resulting in fetal death. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LIBTAYO and for at least 4 months after the last dose.

Adverse reactions • Serious adverse reactions occurred in 35% of patients. Serious adverse reactions that occurred in ≥2% of patients were pneumonitis, cellulitis, sepsis, and pneumonia. The most common Grade 3-4 adverse reactions (≥2%) were cellulitis, anemia, hypertension, pneumonia, musculoskeletal pain, fatigue, pneumonitis, sepsis, skin infection, and hypercalcemia • LIBTAYO was permanently discontinued due to adverse reactions in 8% of patients; adverse reactions resulting in permanent discontinuation were pneumonitis, cough, pneumonia, encephalitis, aseptic meningitis, hepatitis, arthralgia, muscular weakness, neck pain, soft tissue necrosis, complex regional pain syndrome, lethargy, psoriasis, rash maculopapular, proctitis, and confusional state • The most common adverse reactions (incidence ≥20%) were fatigue, rash, and diarrhea musculoskeletal pain, and nausea

Use in specific populations • Lactation: Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO • Females and males of reproductive potential: Verify pregnancy status in females of reproductive potential prior to initiating LIBTAYO

Please see Brief Summary of full Prescribing Information on the following pages. References: 1. LIBTAYO (cemiplimab-rwlc) injection full U.S. prescribing information. Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC. 2. Data on file. Regeneron Pharmaceuticals Inc. 3. Migden MR et al. N Engl J Med. 2018;379(4):341-351. 4. Study of REGN2810 in patients with advanced cutaneous squamous cell carcinoma. ClinicalTrials.gov website. https://clinicaltrials.gov/ct2/show/study/NCT02760498. Updated July 16, 2020. Accessed July 25, 2020.

To learn more about LIBTAYO, speak with your sales representative or visit LIBTAYOhcp.com.

© 2020 Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC. All rights reserved. LIB.20.07.0014 08/20


LIBTAYO® (cemiplimab-rwlc) injection, for intravenous use Brief Summary of Prescribing Information 1 INDICATIONS AND USAGE LIBTAYO is indicated for the treatment of patients with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS 5.1 Severe and Fatal Immune-Mediated Adverse Reactions LIBTAYO is a monoclonal antibody that belongs to a class of drugs that binds to the programmed death receptor-1 (PD-1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response with the potential for breaking of peripheral tolerance and induction of immunemediated adverse reactions. Important immune-mediated adverse reactions listed under Warnings and Precautions may not be inclusive of all possible immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment with PD-1/PD-L1 blocking antibodies, immune-mediated adverse reactions can also manifest after discontinuation of PD-1/PD-L1 blocking antibodies. Immune-mediated adverse reactions affecting more than one body system can occur simultaneously. Early identification and management are essential to ensure safe use of PD-1/PD-L1 blocking antibodies. Monitor for symptoms and signs of immune-mediated adverse reactions. Evaluate clinical chemistries, including liver tests and thyroid function tests, at baseline and periodically during treatment. Institute medical management promptly to include specialty consultation as appropriate. In general, withhold LIBTAYO for Grade 3 or 4 and certain Grade 2 immunemediated adverse reactions. Permanently discontinue LIBTAYO for Grade 4 and certain Grade 3 immune-mediated adverse reactions [see Dosage and Administration (2.2)]. For Grade 3 or 4 and certain Grade 2 immunemediated adverse reactions, administer corticosteroids (1 to 2 mg/kg/day prednisone or equivalent) or other appropriate therapy until improvement to Grade 1 or less followed by a corticosteroid taper over one month [see Dosage and Administration (2.2)]. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroids. Institute hormone replacement therapy for endocrinopathies as warranted. Immune-Mediated Pneumonitis Immune-mediated pneumonitis occurred in 2.4% of 534 patients receiving LIBTAYO, including Grade 5 (0.2%), Grade 3 (0.7%) and Grade 2 (1.3%) [see Adverse Reactions (6.1)]. Pneumonitis led to permanent discontinuation of LIBTAYO in 1.3% of patients. Systemic corticosteroids were required in all patients with pneumonitis, including 85% who received prednisone ≥ 40 mg per day or equivalent. Pneumonitis resolved in 62% of patients. Immune-Mediated Colitis Immune-mediated colitis occurred in 0.9% of 534 patients receiving LIBTAYO, including Grade 3 (0.4%) and Grade 2 (0.6%) [see Adverse Reactions (6.1)]. Colitis led to permanent discontinuation of LIBTAYO in 0.2% of patients. Systemic corticosteroids were required in all patients with colitis, including 60% who received prednisone ≥ 40 mg per day or equivalent. Colitis resolved in 80% of patients. Immune-Mediated Hepatitis Immune-mediated hepatitis occurred in 2.1% of 534 patients receiving LIBTAYO, including Grade 5 (0.2%), Grade 4 (0.2%), and Grade 3 (1.7%) [see Adverse Reactions (6.1)]. Hepatitis led to permanent discontinuation of LIBTAYO in 0.9% of patients. Systemic corticosteroids were required in all patients with hepatitis, including 91% who received prednisone ≥ 40 mg per day or equivalent. Hepatitis resolved in 64% of patients. Immune-Mediated Endocrinopathies Adrenal Insufficiency Adrenal insufficiency occurred in 0.4% of 534 patients receiving LIBTAYO, including Grade 3 (0.2%), and Grade 2 (0.2%) [see Adverse Reactions (6.1)].

Hypophysitis Hypophysitis, which can result in hypopituitarism, occurred in 0.2% of 534 patients receiving LIBTAYO, which consisted of one patient with Grade 3 hypophysitis.

Hypothyroidism Hypothyroidism occurred in 6% of 534 patients receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2 (5.6%). No patients discontinued hormone replacement therapy. Hyperthyroidism Hyperthyroidism occurred in 1.5% of 534 patients receiving LIBTAYO, including Grade 3 (0.2%) and Grade 2 (0.4%). Hyperthyroidism resolved in 38% of patients. Type 1 Diabetes Mellitus Type 1 diabetes mellitus, which can present with diabetic ketoacidosis, occurred in 0.7% of 534 patients, including Grade 4 (0.4%) and Grade 3 (0.4%). Type 1 diabetes mellitus led to permanent discontinuation of LIBTAYO in 0.2% of patients. Immune-Mediated Nephritis with Renal Dysfunction Immune-mediated nephritis occurred in 0.6% of 534 patients receiving LIBTAYO, including Grade 3 (0.4%) and Grade 2 (0.2%) [see Adverse Reactions (6.1)]. Nephritis led to permanent discontinuation of LIBTAYO in 0.2% of patients. Systemic corticosteroids were required in all patients with nephritis, including 67% who received prednisone ≥ 40 mg per day or equivalent. Nephritis resolved in all patients. Immune-Mediated Dermatologic Adverse Reactions Immune-mediated dermatologic reactions, including erythema multiforme and pemphigoid, occurred in 1.7% of 534 patients receiving LIBTAYO, including Grade 3 (1.1%) and Grade 2 (0.6%) [see Adverse Reactions (6.1)]. In addition, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been observed with LIBTAYO and with other products in this class. Systemic corticosteroids were required in all patients with dermatologic reactions, including 89% who received prednisone ≥ 40 mg per day or equivalent. Dermatologic reactions resolved in 33% of patients. Approximately 22% of patients had recurrence of dermatologic reactions after re-initiation of LIBTAYO. Other Immune-Mediated Adverse Reactions The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% in 534 patients who received LIBTAYO [see Adverse Reactions (6.1)] or were reported with the use of other PD-1/PD-L1 blocking antibodies. Severe or fatal cases have been reported for some of these adverse reactions. Neurological: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome / myasthenia gravis, Guillain-Barre syndrome, nerve paresis, autoimmune neuropathy Cardiovascular: Myocarditis, pericarditis, vasculitides Ocular: Uveitis, iritis, and other ocular inflammatory toxicities. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-KoyanagiHarada like syndrome, as this may require treatment with systemic corticosteroids to reduce the risk of permanent vision loss. Gastrointestinal: Pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis Musculoskeletal and Connective Tissue: Myositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatica Hematological and Immunological: Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection 5.2 Infusion-Related Reactions Severe infusion-related reactions (Grade 3) occurred in 0.2% of patients receiving LIBTAYO [see Adverse Reactions (6.1)]. Monitor patients for signs and symptoms of infusion-related reactions. Interrupt or slow the rate of infusion or permanently discontinue LIBTAYO based on severity of reaction [see Dosage and Administration (2.2)]. 5.3 Embryo-Fetal Toxicity Based on its mechanism of action, LIBTAYO can cause fetal harm when administered to a pregnant woman. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immunemediated rejection of the developing fetus resulting in fetal death. Advise women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with LIBTAYO and for at least 4 months after the last dose [see Use in Specific Populations (8.1, 8.3)].


6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling. • Severe and Fatal Immune-Mediated Adverse Reactions [see Warnings and Precautions (5.1)] • Infusion-Related Reactions [see Warnings and Precautions (5.2)] 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data described in Warnings and Precautions reflect exposure to LIBTAYO in 534 patients in two open-label, single-arm, multicohort studies (Study 1423 and Study 1540), including 98 patients with mCSCC (nodal or distant), 65 patients with laCSCC, and 371 patients with other advanced solid tumors. LIBTAYO as a single agent or in combination with chemotherapy or radiation was administered intravenously at doses of 1 mg/kg every 2 weeks (n=27), 3 mg/kg every 2 weeks (n=446), 3 mg/kg every 3 weeks (n=12), 10 mg/kg every 2 weeks (n=6), 200 mg every 2 weeks (n=20) or 350 mg every 3 weeks (n=23). Among the 534 patients, 38% were exposed for ≥ 6 months and 16% were exposed for ≥ 12 months. The data described below reflect exposure to LIBTAYO in 219 patients with advanced CSCC (metastatic or locally advanced disease) in Study 1423 and Study 1540 [see Clinical Studies (14)]. Of these 219 patients, 131 had mCSCC (nodal or distant) and 88 had laCSCC. Patients received LIBTAYO 1 mg/kg every 2 weeks (n=1), 3 mg/kg every 2 weeks (n=162) or 350 mg every 3 weeks (n=56) as an intravenous infusion until disease progression, unacceptable toxicity, or completion of planned treatment. The median duration of exposure was 38 weeks (2 weeks to 110 weeks). The safety population characteristics were: median age of 72 years (38 to 96 years), 83% male, 96% white, and European Cooperative Oncology Group (ECOG) performance score (PS) of 0 (44%) and 1 (56%). The most common adverse reactions reported in at least 20% of patients were fatigue, rash, diarrhea, musculoskeletal pain, and nausea. The most common Grade 3-4 adverse reactions (≥ 2%) were cellulitis, anemia, hypertension, pneumonia, musculoskeletal pain, fatigue, pneumonitis, sepsis, skin infection, and hypercalcemia. LIBTAYO was permanently discontinued due to adverse reactions in 8% of patients; adverse reactions resulting in permanent discontinuation were pneumonitis, cough, pneumonia, encephalitis, aseptic meningitis, hepatitis, arthralgia, muscular weakness, neck pain, soft tissue necrosis, complex regional pain syndrome, lethargy, psoriasis, rash maculopapular, proctitis, and confusional state. Serious adverse reactions occurred in 35% of patients. Serious adverse reactions that occurred in at least 2% of patients were pneumonitis, cellulitis, sepsis, and pneumonia. Table 1 summarizes the adverse reactions that occurred in ≥ 10% of patients and Table 2 summarizes Grade 3 or 4 laboratory abnormalities worsening from baseline in ≥ 1% of patients receiving LIBTAYO. Table 1: Adverse Reactions in ≥ 10% of Patients with Advanced CSCC Receiving LIBTAYO in Study 1423 and Study 1540 Adverse Reactions

LIBTAYO N=219 All Grades %

Grades 3-4 %

34

3

Rashb

31

1

Pruritusc

18

0

Diarrhead

25

0.5

Nausea

21

0

Constipation

13

0.5

Vomiting

10

0.5

General and Administration Site Fatiguea Skin and Subcutaneous Tissue

Gastrointestinal

Musculoskeletal and Connective Tissue Musculoskeletal paine

24

3

Arthralgia

11

1

14

0

Respiratory Coughf

(continued)

Table 1: Adverse Reactions in ≥ 10% of Patients with Advanced CSCC Receiving LIBTAYO in Study 1423 and Study 1540 (continued) Adverse Reactions

LIBTAYO N=219 All Grades %

Grades 3-4 %

11

4

10

0

10

0

Hematology Anemia Endocrine Hypothyroidism Metabolism and Nutrition Decreased appetite

Toxicity was graded per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.4.03 a. Fatigue is a composite term that includes fatigue and asthenia b. Rash is a composite term that includes rash, rash maculopapular, erythema, dermatitis, dermatitis bullous, rash generalized, pemphigoid, rash erythematous, rash macular, rash pruritic, drug eruption, psoriasis, and skin reaction c. Pruritus is a composite term that includes pruritus and pruritus allergic d. Diarrhea is a composite term that includes diarrhea and colitis e. Musculoskeletal pain is a composite term that includes back pain, pain in extremity, myalgia, musculoskeletal pain, and neck pain f. Cough is a composite term that includes cough and upper airway cough syndrome Table 2: Grade 3 or 4 Laboratory Abnormalities Worsening from Baseline in ≥ 1% of Patients with Advanced CSCC Receiving LIBTAYO in Study 1423 and Study 1540 Laboratory Abnormality

Grade 3-4 (%)a

Chemistry Increased aspartate aminotransferase

2

Increased INR

2

Hematology Lymphopenia

9

Anemia

5

Electrolytes Hyponatremia

5

Hypophosphatemia

4

Hypercalcemia

2

Toxicity graded per NCI CTCAE v. 4.03 Percentages are based on the number of patients with at least 1 post-baseline value available for that parameter.

a.

6.2 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to cemiplimab-rwlc in the studies described below with the incidence of antibodies in other studies or to other products may be misleading. Anti-drug antibodies (ADA) were tested in 467 patients who received LIBTAYO. The incidence of cemiplimab-rwlc treatment-emergent ADAs was 1.1% using an electrochemiluminescent (ECL) bridging immunoassay; 0.2% were persistent ADA responses. In the patients who developed anti-cemiplimab-rwlc antibodies, there was no evidence of an altered pharmacokinetic profile of cemiplimab-rwlc. 8 USE IN SPECIFIC POPULATIONS 8.1 Pregnancy Risk Summary Based on its mechanism of action, LIBTAYO can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. There are no available data on the use of LIBTAYO in pregnant women. Animal studies have demonstrated that inhibition of the PD-1/PD-L1 pathway can lead to increased risk of immune-mediated rejection of the developing fetus resulting in fetal death (see Data). Human IgG4 immunoglobulins (IgG4) are known to cross the placenta; therefore, LIBTAYO has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to a fetus.


In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Animal reproduction studies have not been conducted with LIBTAYO to evaluate its effect on reproduction and fetal development. A central function of the PD-1/PD-L1 pathway is to preserve pregnancy by maintaining maternal immune tolerance to the fetus. In murine models of pregnancy, blockade of PD-L1 signaling has been shown to disrupt tolerance to the fetus and to result in an increase in fetal loss; therefore, potential risks of administering LIBTAYO during pregnancy include increased rates of abortion or stillbirth. As reported in the literature, there were no malformations related to the blockade of PD-1/PD-L1 signaling in the offspring of these animals; however, immune-mediated disorders occurred in PD-1 and PD-L1 knockout mice. Based on its mechanism of action, fetal exposure to cemiplimab-rwlc may increase the risk of developing immune-mediated disorders or altering the normal immune response. 8.2 Lactation Risk Summary There is no information regarding the presence of cemiplimab-rwlc in human milk, or its effects on the breastfed child or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment and for at least 4 months after the last dose of LIBTAYO.

8.3 Females and Males of Reproductive Potential Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating LIBTAYO [see Use in Specific Populations (8.1)]. Contraception LIBTAYO can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)].

Females Advise females of reproductive potential to use effective contraception during treatment with LIBTAYO and for at least 4 months after the last dose. 8.4 Pediatric Use The safety and effectiveness of LIBTAYO have not been established in pediatric patients. 8.5 Geriatric Use Of the 219 mCSCC or laCSCC patients who received LIBTAYO in clinical studies, 34% were 65 years up to 75 years and 41% were 75 years or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

Š 2020 Regeneron Pharmaceuticals, Inc., and sanofi-aventis U.S. LLC. All rights reserved. LIB.20.07.0016 07/20


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Indiana www.ismanet.org (800) 257-4762

Nebraska www.nebmed.org (402) 474-4472

South Carolina www.scmedical.org (800) 327-1021

Arizona www.azmed.org (602) 347-6900

Iowa www.iowamedical.org (515) 223-1401

Nevada www.nvdoctors.org (775) 825-6788

South Dakota www.sdsma.org (605) 336-1965

Arkansas www.arkmed.org (800) 542-1058

Kansas www.kmsonline.org (800) 332-0156

New Hampshire www.nhms.org (800) 564-1909

Tennessee www.tnmed.org (615) 385-2100

California www.cmanet.org (800) 786-4262

Kentucky www.kyma.org (502) 426-6200

New Jersey www.msnj.org (609) 896-1766

Texas www.texmed.org (800) 880-1300

Colorado www.cms.org (800) 654-5653

Louisiana www.lsms.org (800) 375-9508

New Mexico www.nmms.org (505) 828-0237

Utah www.utahmed.org (801) 747-3500

Connecticut www.csms.org (203) 865-0587

Maine www.mainemed.com (207) 622-3374

New York www.mssny.org (516) 488-6100

Vermont www.vtmd.org (802) 223-7898

District of Columbia www.msdc.org (202) 466-1800

Maryland www.medchi.org (800) 492-1056

North Carolina www.ncmedsoc.org (919) 833-3836

Virginia www.msv.org (800) 746-6768

Delaware www.medsocdel.org (302) 366-1400

Massachusetts www.massmed.org (781) 893-4610

North Dakota www.ndmed.org (701) 223-9475

Washington www.wsma.org (206) 441-9762

Florida www.flmedical.org (850) 224-6627

Michigan www.msms.org (517) 337-1351

Ohio www.osma.org (800) 766-6762

West Virginia www.wvsma.com (304) 925-0342

Georgia www.mag.org (678) 303-9290

Minnesota www.mnmed.org (612) 378-1875

Oklahoma www.okmed.org (800) 522-9452

Hawaii www.hawaiimedicalassociation.org (808) 536-7702

Mississippi www.msmaonline.com (601) 853-6733

Oregon www.theoma.org (503) 619-8000

Wisconsin www.wisconsinmedicalsociety.org (866) 442-3800

Missouri www.msma.org (573) 636-5151

Pennsylvania www.pamedsoc.org (855) 726-3348

Idaho www.idmed.org (208) 344-7888

28 | PHYSICIANS OFFICE RESOURCE

Wyoming www.wyomed.org (307) 635-2424


8708

8709

8710


DIRECTORY

COMPANIES BY PRODUCT

PRODUCT CATEGORIES

categories —

A1C Abbott Rapid Diagnostics www.alere.com

ALLERGY Jant Pharmacal www.accutest.net

BRAIN ASSESMENT Evoke Neuroscience www.evokeneuroscience.com

CENTRIFUGES Drucker Diagnostics www.druckerdiagnostics.com

Hemocue America www.Hemocue.us

Jant Pharmacal www.medicaldevicedepot. com

CARDIO VASCULAR/ PULMONARY Abbott Rapid Diagnostics www.alere.com

CHEMISTRY ANALYZERS Abbott Diagnostics www.corelaboratory.abbott

Siemens Healthcare Diagnostics www.healthcare.siemens.com ABI Huntleigh Diagnostics www.huntleigh-diagnostics. com Medical Device Depot www.medicaldevicedepot. com Newman Medical www.newman-medical.com ACNE TREATMENT Theravant Corp www.theraclear.com AESTHETICS Aerolase www.aerolase.com Alma Lasers Cutera, Inc. CryoProbe www.ho-equipments.com DermaMed International, Inc. Lipo Sculpting Solutions www.liposculptingsolutions. com Orasure Histofreezer www.histofreezer.com Premier Medical Products www.premusa.com

30 | PHYSICIANS OFFICE RESOURCE

Asthma Testing Micro Direct www.mdspiro.com

Brilliant Medical www.brilliantmedical.com

Abbott Point of Care www.pointofcare.abbott/us/ en/home

Vitalograph www.vitalograph.com

Futuremed America, Inc. www.futuremedamerica.com

AMS Diagnostics www.amsdiagnostics.com

AUDIOMETRY Otovation, LLC

Medical Device Depot www.medicaldevicedepot. com

Beckman Coulter www.beckmancoulter.com

Ototronix Diagnostics Augmented Medicine Medpod www.medpodhealth.com BLOOD GAS Abbott Point of Care www.pointofcare.abbott/us/ en/home Nova Biomedical BLOOD PRESSURE Medical Device Depot www.medicaldevicedepot. com Vitalograph www.vitalograph.com

Micro Direct, Inc. www.mdspiro.com Midmark Diagnostics, Inc. www.midmark.com MIR – Medical International Research www.spirometry.com Nasiff Associates, Inc. www.nasiff.com ndd Medical Technologies www.nddmed.com Nihon Kohden Nonin Medical, Inc.

Welch Allyn www.welchallyn.com

Schiller America, Inc. www.schiller.ch/us

BONE HEALTH GE Healthcare www.gehealthcare.com

SDI Diagnostics, Inc.

Hologic, Inc.

Vitalograph www.vitalograph.com Welch Allyn www.welchallyn.com

Arkray USA, Inc. Carolina Liquid Chemistries, Inc. www.carolinachemistries.com ELITech Group www.elitechgroup.com Horiba Medical www.horiba.com/us/en/ medical Jant Pharmacal www.accutest.net Medica Corporation www.medicacorp.com Randox Laboratories, USA www.randox.com Roche www.roche.com Sekisui www.sekisuidiagnostics.com Vital Diagnostics www.vitaldiagnostics.com


CHOLESTEROL & TRIGLYCERIDE TESTING Abbott Point of Care www.pointofcare.abbott/us/ en/home

Newman Medical www.newman-medical.com

Medica Corporation www.medicacorp.com

Wallach Surgical Devices www.wallachsurgical.com

Opti Medical Systems, Inc.

Abbott Rapid Diagnostics www.alere.com

DRUGS OF ABUSE TESTS Carolina Liquid Chemistries www.carolinachemistries.com

Alfa Wassermann, Inc www.alfawassermannus.com Arkray USA, Inc. Beckman Coulter, Inc. www.beckman.com Carolina Liquid Chemistries, Inc. www.carolinachemistries.com Horiba Medical www.horiba.com/us/en/ medical Medica Corporation www.medicacorp.com Ortho-Clinical Diagnostics Polymer Technology Systems Randox Laboratories, Inc. www.randox.com Roche go.roche.com/rochelancets COAGULATION Roche www.roche.com

Horiba www.horiba.com/us/en/ medical Laboratory Consulting, LLC www.urinedrugscreenconsulting.com Randox Laboratories, Inc. www.randox.com Sekisui www.sekisuidiagnostics.com EAR, NOSE & THROAT Bionix Medical Technologies Brilliant Medical www.brilliantmedical.com

Roche www.roche.com ENDOSCOPY Panasonic USA Pentax Medical E-PRESCRIBING Amazing Charts www.amazingcharts.com DrFirst www.drfirst.com ESR ALCOR Scientific www.alcorscientific.com EXAM ROOM FURNITURE Brewer Medical www.brewercompany.com

HEINE North America

Medical Device Depot www.medicaldevicedepot. com

Med-Electronics, Inc. www.med-electronics.com

Midmark Corporation www.midmark.com

Welch Allyn, Inc. www.welchallyn.com

Vinyl Crafters www.vcupholstery.com

ECG Edan Diagnostics

FECAL OCCULT BLOOD Beckman Coulter, Inc. www.beckmancoulter.com

GE Healthcare Technologies www.gehealthcare.com

GASTROINTESTINAL DISEASE TESTING BioFire www.biofiredx.abbott GLUCOSE TESTING Abbott Point of Care www.corelaboratory.abbott Abbott Rapid Diagnostics www.alere.com Hemocue, Inc. www.hemocue.com Jant Pharmacal www.jantdx.com Nova Biomedical Roche go.roche.com/rochelancets H. PYLORI Exalenz www.exalenz.com HCV – HIV TESTING Orasure www.orasure.com HEMATOLOGY ANALYZERS Abbott www.corelaboratory.abbott/ hematology ALCOR Scientific www.alcorescientific.com Beckman Coulter, Inc. www.beckmancoulter.com

Clinical Genomics www.clinicalgenomics.com

Drucker Diagnostics, Inc. www.qbcdiagnostics.com

Hemosure, Inc. www.hemosure.com

Hemocue, Inc. www.hemocue.com

Midmark Diagnostics, Inc. www.midmark.com

Jant Pharmacal www.accutest.net

Mortara www.mortara.com

Sekisui www.sekisui.com

Horiba Medical www.horiba.com/us/en/ medical

CryoConcepts, LP www.cryoconcepts.com

Schiller America, Inc. www.schilleramerica.com

DEFIBRILLATORS Cardiac Science www.cardiacscience.com

Vitalograph www.vitalograph.com

FLU TESTING BD www.BD.com/veritorsystem

Roche go.roche.com/rochelancets CONJUNCTIVITIS TESTS RPS Diagnostics www.rpsdetectors.com CRYOSURGICAL DEVICES CryoProbe www.ho-equipments.com

Medical Device Depot www.medicaldevicedepot. com DOPPLERS Huntleigh Diagnostics www.huntleigh-diagnostics. com Medical Device Depot www.medicaldevicedepot. com

Medical Device Depot www.medicaldevicedepot. com

Welch Allyn www.welchallyn.com EDUCATION AAFP www.aafp.org COLA www.cola.org ELECTROLYTE Abbott Point of Care www.pointofcare.abbott/us/ en/home

BioFire www.BioFireDx.com Cepheid www.cepheid.com

Jant Pharmacal www.accutest.net Sysmex America, Inc. www.sysmex.com/us HEMOGLOBIN ANALYZERS Abbott Rapid Diagnostics www.alere.com EKF Diagnostics

Roche www.Roche.com

Hemocue, Inc. www.hemocue.com

Sekisui www.sekisuidiagnostics.com

Masimo Corporation www.masimo.com IMMUNOASSAY INSTRUMENTS Abbott Diagnostics www.corelaboratory.abbott 2021 · BUYERS GUIDE | 31


BD www.bd.com/veritorsystem Beckman Coulter, Inc. www.beckmancoulter.com

DIRECTORIES

NanoEnTek www.nanoentek.com Sekisui Diagnostics www.sekisuidiagnostics.com INFECTIOUS DISEASE BioFire www.BioFireDx.com

PRODUCT CATEGORIES

Roche www.roche.com Sekisui www.sekisui.com LABORATORY INFORMATION SYSTEMS Alfa Wassermann, Inc Jant Pharmacal www.accutest.net Medicus LIS www.medicuslis.com Orchard Software LABORATORY SANATIZERS Clorox PDI LAB SERVICES AAFP www.aafp.org COLA www.cola.org COLA Resources Inc. www.criedu.org Laboratory Consulting, LLC www.onlinelabhelp.com Medicus Middleware www.medicusmiddleware. com My Inspection http://.myinspection.us LANCETS Roche go.roche.com/rochelancets LEAD TESTING Meridian Bioscience www.magellandx.com LIPID TESTING Abbott Rapid Diagnostics www.alere.com

32 | PHYSICIANS OFFICE RESOURCE

METABOLIC TESTING Korr Medical Technologies, Inc. www.korr.com MOBILE HEALTH TECHNOLOGY Medpod www.medpodhealth.com MONITORS Edan Diagnostics GE Healthcare Technologies www.gehealthcare.com Medical Device Depot www.medicaldevicedepot. com Midmark www.midmark.com Welch Allyn www.welchallyn.com NEUROLOGICAL TESTING Advanced Clinical Products www.advancedclinicalproducts.com Brilliant Medical www.brilliantmedical.com Evoke Neuroscience www.evokeneuroscience.com PAIN PRACTICE LAB Mercedes Medical www.mercedesmedical.com PHOTOTHERAPY SOLUTIONS Daavlin Company www.daavlin.com PRACTICE MANAGEMENT Antek Healthware

Sekisui www.sekisuidiagnostics.com SLEEP DISORDERS ResMed Corp. Sleep Solutions SPIROMETRY Futuremed America, Inc. www.futuremedamerica.com Medical Device Depot www.medicaldevicedepot. com Micro Direct, Inc. www.mdspiro.com Midmark Diagnostics, Inc. www.midmark.com MIR â&#x20AC;&#x201C; Medical International Research www.spirometry.com ndd Medical Technologies www.nddmed.com Vitalograph www.vitalograph.com Welch Allyn www.welchallyn.com STREP TESTING Alere, Inc. www.alere.com BD www.BD.com/veritorsystem Cepheid www.cepheid.com Beckman Coulter, Inc. www.beckmancoulter.com

Athena Health

LifeSign, LLC www.lifesignmed.com

ZirMed www.zirmed.com

Roche www.roche.com

PT/INR Roche www.Roche.com

Sekisui www.sekisuidiagnostics.com

PULSE OXIMETERS Masimo Corporation www.masimo.com REAGENTS Beckman Coulter www.beckmancoulter.com Carolina Liquid Chemistries, Inc. www.carolinachemistries.com Randox Laboratories, USA www.randox.com

TELEHEALTH Medpod www.medpodhealth.com THERMOMETERS Exergen Corporation www.exergen.com ULTRASOUND Interson www.interson.com Samsung Medison www.samsungmedison.com

URINALYSIS Abbott Rapid Diagnostics www.alere.com Jant Pharmacal www.accutest.net LifeSign, LLC www.lifesignmed.com Roche www.roche.com Siemens Healthcare Diagnostics www.healthcare.siemens.com WEIGHT MANAGEMENT Korr Medical Technologies, Inc. www.korr.com


Why You Should Be Doing Spirometry

8712

8711

8713 It’s Important - Spirometry is the gold standard for the diagnosis and management of both asthma and COPD. It’s Good Medicine - Your patients are correctly diagnosed and treated more accurately and conveniently in your office. The earlier you detect the disease; the easier you can treat it. It’s Easy - A spirometry test takes less than five minutes to perform. It’s Good Business - Office spirometry is third party reimbursable and will pay for itself within the first year of purchase. It’s Safe - The SpiroSafe filter is single use viral/bacterial filters that helps to protect your patients and staff. It is >99% effective against viral and bacterial cross-contamination. Why Micro Direct? - Micro Direct’s spirometry experts will help you choose the right spirometer and then FULLY support your staff from training on how to use the spirometer through billing questions; and all Micro Direct spirometers are backed by a 30-day money back guarantee.

Micro Direct, Inc. 803 Webster Street Lewiston, ME 04240 1-888-287-8556 sales@mdspiro.com

www.mdspiro.com

8714


IMPORTANT SAFETY INFORMATION WARNINGS AND PRECAUTIONS Few cases (0.36%) of adverse reactions of cystitis, pyelonephritis and other upper urinary tract infection (UTI) have been reported in Phexxi™ clinical studies. Of these, one case of pyelonephritis was considered serious and required hospitalization. Avoid use of Phexxi™ in females of reproductive potential with history of recurrent urinary tract infection or urinary tract abnormalities. ADVERSE REACTIONS Most common adverse reactions were vulvovaginal burning sensation, vulvovaginal pruritus, vulvovaginal mycotic infection, urinary tract infection, vulvovaginal discomfort, bacterial vaginosis, vaginal discharge, genital discomfort, dysuria, and vulvovaginal pain. Patients should be counseled on the following: • To contact and consult with their healthcare provider for severe or prolonged genital irritation or experiencing urinary tract symptoms. • To discontinue Phexxi™ if they develop a local hypersensitivity reaction. • That Phexxi™ does not protect against HIV infection or other sexually transmitted infections. To report SUSPECTED ADVERSE REACTIONS, contact Evofem at toll-free phone 1-833-EVFMBIO or you may contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


INTRODUCING A non-hormonal, in-the-moment contraceptive

pHinally! There’s Phexxi™ An FDA-approved contraceptive vaginal gel designed to meet her needs

NON-HORMONAL WOMAN CONTROLLED WORKS IMMEDIATELY

Phexxi™ is a vaginal pH modulator (VPM)— a first-in-class, non-hormonal prescription contraceptive that works immediately to maintain the vagina’s acidic pH in the presence of semen.1-4

Discover

why Phexxi™ may be an option for your patients by visiting

HCP-Phexxi.com/contraceptive

INDICATIONS AND USAGE Phexxi™ is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. LIMITATIONS OF USE Phexxi™ is not effective for the prevention of pregnancy when administered after intercourse. Please see full Prescribing Information for Phexxi™. Please see Brief Summary on the following page. REFERENCES: 1. Phexxi™ [Prescribing Information]. Evofem Biosciences, Inc: San Diego, CA; May 2020. 2. Phexxi™ Vaginal Gel. Medi-Span®; June 8, 2020. 3. Bayer LL, Jensen JT. ACIDFORM: a review of evidence. Contraception. 2014;90:11-18. 4. Nayak S, Avery A, McLeod Griffiss J, Charles CD, Culwell KR. A randomized placebo-controlled pilot study of the effect and duration of Amphora, a multipurpose vaginal pH regulator, on vaginal pH. Clin Exp Obstet Gynecol. 2019;46(5):736-742.

Trademarks are owned by Evofem Biosciences. © 2020 Evofem Biosciences. EVFM-US-000071 • August 2020 • Produced in USA.


Among subjects who used PHEXXI in Studies 1 and 2, 1.6% discontinued from the clinical trials due to an adverse reaction. The most common adverse reactions leading to study discontinuation were vulvovaginal burning sensation (0.7%); and vulvovaginal pruritus and vulvovaginal discomfort (0.1% each).

BRIEF SUMMARY: Consult the Package Insert for complete Prescribing Information INDICATIONS AND USAGE PHEXXITM is indicated for the prevention of pregnancy in females of reproductive potential for use as an on-demand method of contraception. LIMITATIONS OF USE PHEXXI is not effective for the prevention of pregnancy when administered after intercourse. WARNINGS AND PRECAUTIONS Cystitis and Pyelonephritis Among 2804 subjects who received PHEXXI in Studies 1 and 2, 0.36% (n=10) reported adverse reactions of cystitis, pyelonephritis, or other upper urinary tract infection (UTI). Of these, one case of pyelonephritis was considered serious and required hospitalization. Avoid use of PHEXXI in females of reproductive potential with a history of recurrent urinary tract infection or urinary tract abnormalities. ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of PHEXXI (pre-filled applicator with 5-gram dose) has been evaluated in two clinical trials (Study 1 and Study 2) in 2804 subjects (over 19,000 cycles of exposure). The racial/ethnic distribution was 66% White, 27% Black or African American, 2% Asian, 1% American Indian or Alaska Native, 0.3% Native Hawaiian or Pacific Islander, and 5% other; 32% of the study population was Hispanic. Study 1 included a one-year extension phase where 342 U.S. subjects were exposed to PHEXXI for 13 cycles. Hypersensitivity Reaction: Of the 2804 PHEXXI-treated subjects in Studies 1 and 2, one subject reported a suspected drug hypersensitivity. Avoid PHEXXI use in females of reproductive potential with suspected hypersensitivity to the ingredients in PHEXXI. The most common adverse reactions (≥10%) in the U.S. population in Studies 1 and 2 (n = 2480) were: vulvovaginal burning sensation (18.0%) and vulvovaginal pruritus (14.5%). The majority of these adverse reactions were mild and few led to discontinuation. Table 1 summarizes the most common adverse reactions (≥ 2%) reported by subjects using PHEXXI in the U.S. Table 1. Adverse Reactions that Occurred in ≥ 2% of Subjects Who Used PHEXXI to Prevent Pregnancy (Studies 1 and 2 – U.S. population only)

Adverse Reaction Vulvovaginal Burning Sensation Vulvovaginal Pruritus Vulvovaginal Mycotic Infection* Urinary Tract Infection†,‡ Vulvovaginal Discomfort Bacterial Vaginosis Vaginal Discharge Genital Discomfort Dysuria Vulvovaginal pain

PHEXXI (N=2480) (%) 18.0 14.5 9.1 9.0 9.0 8.4 5.5 4.1 3.1 2.1

*Includes preferred terms (PT) vulvovaginal mycotic infection and vulvovaginal candidiasis. † Includes PTs urinary tract infection, streptococcal urinary tract infection, Escherichia urinary tract infection, and urinary tract infection bacterial. ‡ Does not include PTs cystitis, kidney infection, and pyelonephritis [see Warnings and Precautions (5.1) of PHEXXI Full Prescribing Information].

Adverse Reactions in Male Partners: Among male partners of subjects who used PHEXXI for contraception in Study 2, 9.8% (131 of 1330) reported symptoms of local discomfort (burning, itching, pain, and “other”). Of these local discomfort symptoms, 74.7% were mild, 21.4% were moderate, and 3.9% were severe. Two subjects discontinued participation in the study due to male partner symptoms. USE IN SPECIFIC POPULATIONS Pregnancy Risk Summary There is no use for PHEXXI in pregnancy; therefore, discontinue PHEXXI during pregnancy. There are no data with the use of PHEXXI in pregnant women or animals. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. Lactation Risk Summary There are no data on the presence of lactic acid, citric acid, and potassium bitartrate or their metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Pediatric Use The safety and effectiveness of PHEXXI have been established in females of reproductive potential. Efficacy is expected to be the same for post-menarchal females under the age of 17 as for users 17 years and older. The use of PHEXXI before menarche is not indicated. PATIENT COUNSELING INFORMATION See FDA-approved patient labeling. Advise the patient to read the Patient Information and FDA-approved patient labeling (Instructions for Use). Advise the patient: • To intravaginally administer the contents of one pre-filled single-dose applicator of PHEXXI before each episode of vaginal intercourse and to administer an additional dose if intercourse does not occur within one hour of administration [see Dosage and Administration (2.1) of PHEXXI Full Prescribing Information]. • To consult their healthcare provider for severe or prolonged genital irritation [see Adverse Reactions (6.1) of PHEXXI Full Prescribing Information]. • To discontinue PHEXXI if they develop a local hypersensitivity reaction [see Adverse Reactions (6.1) of PHEXXI Full Prescribing Information]. • To contact their health care provider if experiencing urinary tract symptoms [see Warnings and Precautions (5.1) of PHEXXI Full Prescribing Information]. • That PHEXXI does not protect against HIV infection and other sexually transmitted infections.

Manufactured for Evofem, Inc., a wholly owned subsidiary of Evofem Biosciences, Inc., 12400 High Bluff Drive, Suite 600, San Diego, CA 92130 Trademarks are owned by Evofem Biosciences. © 2020 Evofem Biosciences. U.S. Patent 6,706,276 REFDOC-000554 To report SUSPECTED ADVERSE REACTIONS, contact Evofem at toll-free phone 1-833-EVFMBIO or you may contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


2021

PRODUCT focus guide —

ABI PAGE 38 AESTHETICS PAGE 38 ALL IN ONE DIAGNOSTIC SOLUTIONS PAGE 39 BRAIN FUNCTION ASSESSMENT PAGE 39 BREATH TESTING PAGE 40 CARDIOLOGY PAGE 40, 42

CHEMISTRY ANALYZERS PAGES 42, 44, 46 CHOLESTEROL PAGE 46 CLIA WAIVED PRODUCTS PAGES 48-52 COVID-19 TESTING PAGES 53-54 CRYOSURGERY PAGES 54-55 DRUG TESTING PAGES 55-56 EXAM ROOM EQUIPMENT PAGES 56-57

FLU TESTING PAGES 57-58

PULSE OXIMETR PAGES 65-66

FOBT PAGE 59

REAGENTS PAGE 66

HBA1C PAGE 59

RSV TESTING PAGES 66-68

HEMATOLOGY PAGES 60-63

SPIROMETRY PAGE 69

IMMUNOASSAY ANALYZERS PAGE 64

STI PAGE 69

LAB SERVICES PAGES 64-65 LIPID TESTING PAGE 65

STREP TESTING PAGE 70 TELEMEDICINE PAGE 71 URINALYSIS PAGE 71

2021 · BUYERS GUIDE | 37


ABI PRODUCT FOCUS

PAD TESTING SYSTEMS IDEAL FOR PRIMARY CARE TO VASCULAR SPECIALISTS From Newman Medical 8715

Your patients Trust You to find their PAD • You have many high risk patients, including anyone over 65 or diabetics or smokers • Even if they are unaware of their PAD, 25% will have a heart attack or stroke within 5 years if not managed • Patients often mistake symptoms of PAD for arthritis. simpleABI Cuff-Link systems are easy to learn and use • Push button remote, automatic calculations/waveforms • PC based – reports are easy to save and share Excellent Value and Reimbursements • One test per week pays off system in less than one year • Medicare reimbursements range from $80 to $220 depending on location and test

View Brochures, Videos & More at POR.io Enter Number 8715 in the Search Area

AESTHETICS PORTABLE AESTHETIC LASER From Aerolase

A highly versatile Medical Aesthetic Laser to add substantial new cash revenues to your practice. Your patients are seeking aesthetic and medical laser treatments from a quality medical care provider such as you. Aerolase - a company with deep expertise in compact laser technology - has developed a breakthrough in the form of a versatile, safe and gentle laser for a wide range of treatments. It is also a compact, affordable laser.

8716

View Brochures, Videos & More at POR.io Enter Number 8716 in the Search Area

8717

LASER LIPO NON-INVASIVE INSTANT INCH LOSS RESULTS From Laser Lipo Ltd The FDA Approved, Strawberry Laser Lipo is a ground-breaking treatment offering non-invasive, instant inch loss results to the Abdomen, Hips, Thighs, Arms, Back Fat, Buttocks, Male Chest and Knees, without any pain or downtime. The clinically proven, noninvasive laser treatment penetrates the skin to selectively target the fat cells underneath, leaving blood vessels, nerves and other tissue undisturbed. Only $24,750 and 0% in-house no credit check financing.

View Brochures, Videos & More at POR.io Enter Number 8717 in the Search Area

38 | PHYSICIANS OFFICE RESOURCE


ALL-IN-ONE DIAGNOSTIC SOLUTIONS

From MedPod The Medpod Medical Cart optimizes productivity and load balancing by enabling access to remote physicians during high volume periods or to reach low-density populations. Medpod’s proprietary software integrates with a wide range of professional medical devices and gives the remote provider control of the devices to conduct an examination that is on par with a faceto-face visit. Patient images, audio and data can be captured, annotated, tagged and uploaded in real-time or stored and forwarded into the EHR by either remote or local provider.

8718

View Brochures, Videos & More at POR.io Enter Number 8718 in the Search Area

DEFINING MOBILE TELEDIAGNOSTICS From MedPod With the ability to deploy into a medical office in less than 2 minutes, MobileDoc is the ultimate portable practice. Revolutionary in its compact and mobile design, MobileDoc integrates best-in-class professional medical-grade devices with state-of-the-art HD video and EHR connectivity. Physicians can provide care remotely that is on par or better than a face-to-face visit, including conducting basic exams, checking vitals, and performing specialty testing— shattering the boundaries of traditional care.

8719

View Brochures, Videos & More at POR.io Enter Number 8719 in the Search Area

BRAIN FUNCTION ASSESSMENT MEMORY LOSS BIOMARKERS TO AID IN DIAGNOSIS IN PRIMARY CARE PRACTICES From Evoke Neuroscience 8720

The eVox® System is an FDA 510(k) cleared medical device to aid primary and specialty care physicians in diagnosis of memory loss and other cognitive disorders. eVox® measures memory loss biomarkers that may aid in detecting memory loss sooner, identifying the root cause of memory loss, and performing a differential diagnosis. eVox® procedures are performed in-office and are reimbursable by Medicare and commercial payers.

View Brochures, Videos & More at POR.io Enter Number 8720 in the Search Area

2021 · BUYERS GUIDE | 39

PRODUCT FOCUS

OPTIMIZE PRODUCTIVITY AND EXPAND YOUR PRACTICE


PRODUCT FOCUS

BREATH TESTING H2 CHECK – BREATH HYDROGEN MONITOR

8721

From Micro Direct

Micro Direct is pleased to offer the H2 Check breath hydrogen monitor for simple screening of lactose or other sugar mal-absorption, bacterial overgrowth and the measurement of intestinal transit time. The H2 Check provides a fast and easy-to-read display of expired Hydrogen levels in ppm. Exhaling slowly through the H2 Check is all that is required to obtain a measurement. Please call 800-588-3381 or visit our website www.mdspiro.com for more information.

View Brochures, Videos & More at POR.io Enter Number 8721 in the Search Area

VIRAL/BACTERIAL MOUTHPIECE FOR CO BREATH TESTING From Micro Direct

8722

Micro Direct is pleased to introduce the NEW SafeBreath filter. It is the only viral/bacterial filtered mouthpiece for carbon monoxide (CO) breath testing available on the market. SafeBreath is a unique solution offering a combined filter and cardboard mouthpiece with >99% protection against both bacteria and viruses. Using SafeBreath not only protects your patient from potential cross infection during testing but also protects and increases the life of your fuel cell and eliminates the need for and cleaning of the plastic mouthpiece adapter! The SafeBreath (order #FM200) is packaged in a handy dispenser box for easy storage and dispensing.

View Brochures, Videos & More at POR.io Enter Number 8722 in the Search Area

CARDIOLOGY EASY, INTEGRATED WITH-PATIENT TESTING I-STAT Testing SYSTEM Easy, Integrated With-Patient From Point of Care at Abbott i-STAT System from Point of Care at Abbott The handheld i-STAT System offers a broad menu of diagnostic tests

the patient’s side in offers just minutes. With just a fewof drops of blood, tests at th The handheldati-STAT System a broad menu diagnostic the i-STAT System delivers real time, lab-accurate results for a wide patient’s side range in just minutes. With just a few of blood,cardiac the i-STAT of tests, including chemistries, blooddrops gas, coagulation, markers, and more. Minimize delays and wasted time with on-side System delivers real time, lab-accurate results for a wide range of tests, tests. Easy, intuitive operation. including chemistries, blood gas, coagulation, cardiac markers, and more 8723 For intended use andtime complete information, visit pointofMinimize delays and wasted withproduct on-site tests. Easy, intuitive operati care.abbott.

For intended useFor and complete product information, visit pointofcare.abbott. in vitro diagnostic use only. This material is intended for a U.S.

For in vitro diagnostic use only.only. This material for aof U.S. audience only. Office Reaudience i-STAT isis aintended trademark Abbott. Physician i-STAT is a trademark of Abbott. Physician Office Resource — i-STAT Product Description source i-STAT Product Description US 3064.REV1 08/20 – US 3064.REV1 08/2

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GET BETTER OUTCOMES WITH CRYOSURGERY

NEW FOR

8725

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Your choice of a cryosurgical device has a big impact on patient outcomes. CryoConcepts has the broadest line of cryosurgical equipment in the world and our 28 years of experience is built into every single product.

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8724

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PRODUCT FOCUS

CARDIOLOGY ACCURATE, ACTIONABLE RESULTS FROM THE LEADER IN POINT-OFCARE LIPID TESTING From Abbott The CLIA-waived Alere Cholestech LDX™ Analyzer is engineered for confidence, providing accurate, actionable, and readily accessible results that have set the standard in point-of-care lipid profile, cholesterol, and glucose testing. Results are easy to obtain. Fingerstick sampling and a small sample size (40μL) makes results less painful and time consuming.

8726

View Brochures, Videos & More at POR.io Enter Number 8726 in the Search Area

CHEMISTRY ANALYZERS EASY, INTEGRATED WITH-PATIENT TESTING I-STAT SYSTEM

Easy, Integrate i-STAT System

From Point of Care at Abbott

The handheld i-STAT System offers a broad menu of diagnostic tests at the patient’s side in just minutes. With just a few drops of blood, the i-STAT System delivers real time, lab-accurate results for a wide range of tests, including chemistries, blood gas, coagulation, cardiac markers, and more. Minimize delays and wasted time with on-side tests. Easy, intuitive operation. For intended use and complete product information, visit pointofcare.abbott.

The handheld i-S patient’s side in System delivers including chemis 8727 Minimize delays

For in vitro diagnostic use only. This material is intended for a U.S. audience only. i-STAT is a trademark of Abbott. Physician Office Resource i-STAT Product Description — US 3064.REV1 08/20

For intended use an

For in vitro diagnostic us i-STAT is a trademark of

View Brochures, Videos & More at POR.io Enter Number 8727 in the Search Area

FULL COMPLEMENT OF CLIA-WAIVED

Full Complement of CLIA-waived Blood Chemistry Tests BLOOD CHEMISTRY TESTS PICCOLO ® Chemistry Analyzer from Abbott Piccolo Xpress

XPRESS® CHEMISTRY ANALYZER

The Piccolo From XpressAbbott Chemistry Analyzer provides physician offices with lab-accurate results for a broad range of CLIA-waived general chemistry The Piccolo Xpress Chemistry Analyzer provides physician tests, including metabolic panels, lipids, kidney offices with lab-accurate resultsliver, for a and broad range function, of CLIA- and more with just 100waived microliters of chemistry blood. Easy toincluding use, themetabolic Piccolo Xpress general tests, panels, provides lipids, live, andvisit, kidney function, and more withdecisions, just 100 results during a patient’s accelerating treatment increasing microliters of blood. Easy to use, the PIccolo Xpress provides 8728 efficiency, and supporting patient satisfaction. Automated quality control on results during a patient’s visit, accelerating treatment decisions, every test helps ensure accuracy. increasing efficiency, and supporting patient satisfaction. Automated quality control on every test helps ensure accuracy. For in vitro diagnostic use only. This material is intended for a U.S. audience only. Piccolo Xpress is aView registered trademark of Abaxis, Inc. and by Abbott Point of Care. Brochures, Videos &distributed More at POR.io Physician Office Resource Piccolo Product Description – US 3065.REV1 08/20

Enter Number 8728 in the Search Area

42 | PHYSICIANS OFFICE RESOURCE


TO X I C O LO G Y S C R E E N I N G

SIMPLIFIED

8729

Comprehensive toxicology menu now with 14 CLIA1 categorized moderately complex assays.

IMMTOX™ 270 BENCHTOP ANALYZER Toxicology screening solutions for physician offices, treatment centers and laboratories. n

25 assay menu

n

Up to 270 tests per hour

n

Compact footprint

n

Quality products, service and reliability

COMPLETE LABORATORY SOLUTIONS From consultation, to licensure and compliance, the Abbott Clinical Lab Solutions team has you covered.

CONTACT ABBOTT CLINICAL LAB SOLUTIONS. CALL 888-831-6850 | EMAIL: CLS_SALES@ABBOTT.COM 1. Clinical Laboratory Improvement Amendments (CLIA) © 2020 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners. Any photos displayed are for illustrative purposes only. MKT52247 REV1 08/20


PRODUCT FOCUS

CHEMISTRY ANALYZERS RX DAYTONA+ From Randox Laboratories The RX daytona+ is a fully automated, benchtop, clinical chemistry analyzer capable of performing high quality testing, with a combined throughput of 450 tests per hour, for accurate results you can trust. The most versatile analyzer in its class, the RX daytona+ combines robust hardware and intuitive software with the world leading RX series test menu for unrivaled performance, with direct HbA1c testing capabilities.

View Brochures, Videos & More at POR.io Enter Number 8730 in the Search Area

8730

DRUGS OF ABUSE TESTING AND ROUTINE CHEMISTRY PANELS ON A SINGLE ANALYZER

8731

From Carolina Liquid Chemistries Carolina Liquid Chemistries Corp. announces the successful launch of Medica Corporation’s high-speed benchtop analyzer, the EasyRA®. The updated analyzer now operates at a photometric rate of up to 240 tests per hour or up to 480 tests per hour with ISE. The EasyRA urine drug screening and general chemistry reagents are CLIA categorized as moderately complex. This all-in-one system allows clinical laboratories to screen for drugs of abuse in urine while also allowing healthcare providers to assess routine chemistry panels on a single analyzer.

View Brochures, Videos & More at POR.io Enter Number 8731 in the Search Area

8732

Toxicology Screening Simplified Abbott’s ImmTox 270 Benchtop Analyzer Now with 14 assays CLIA Categorized as Moderate Complexity From Abbott The ImmTox270 benchtop analyzer offers comprehensive toxicology screening solutions for physician offices, treatment centers and independent laboratories. Broad test menu with over 20 assays to choose from including 14 that are now available as moderately complex. With complete laboratory solutions from consultation to licensure, and compliance the Abbott Clinical Laboratory Solutions team has you covered.

View Brochures, Videos & More at POR.io Enter Number 8732 in the Search Area 44 | PHYSICIANS OFFICE RESOURCE


8733

Bionet CardioCare 2000: $1,255.00 Schiller AT-2 Plus: $2,626.00* *add Spirometry: $649.00 Burdick ELI 280: $4,088.00 Welch Allyn CP150 w/ Interp: $3,465.00

8734

The Adview 2 is still the only truly modular diagnostic station that grows with your needs. Start with blood pressure and choose temperature or pulse oximetry option at the time of purchase.

8735 8736 8737

8738 8739

8740

Coaxial Ophth, Fiber Optic Oto, Speucla Dispenser, Aneroid BP, Wall Transformer and Wall Board without Thermometer: $979.00 with Thermometer: $1,416.00

8741

8743

8744

8742


PRODUCT FOCUS

CHEMISTRY ANALYZERS

RX IMOLA From HORIBA Medical 8745

The RX imola is a cost-effective system that delivers consistent high-quality results. Capable of handling the workload of a medium to high throughout laboratory and a combined throughput of 560 tests per hour, the RX imola provides rapid, comprehensive testing on a small footprint analyzer when it matters most, with direct HbA1c testing capabilities.

View Brochures, Videos & More at POR.io Enter Number 8745 in the Search Area

PENTRA C400 CHEMISTRY ANALYZER

8746

From HORIBA Medical One benchtop, not a whole lab! No water system, drain or special electrical connected required to operate the Pentra C400 chemistry analyzer. Now you can have the power of a floor model analyzer on the benchtop! The Pentra C400 chemistry system processes up to 420 tests/hr including ISEs and offers routine metabolic assays, TDMs, DAUs and Adulterants, HbA1c and Vitamin D tests. With 40 open channels, you can add much more for a complete menu to meet your practice needs.

View Brochures, Videos & More at POR.io Enter Number 8746 in the Search Area

CHOLESTEROL ACCURATE, ACTIONABLE RESULTS FROM THE LEADER IN POINT-OFCARE LIPID TESTING From Abbott

8747

The CLIA-waived Alere Cholestech LDX™ Analyzer is engineered for confidence, providing accurate, actionable, and readily accessible results that have set the standard in point-of-care lipid profile, cholesterol, and glucose testing. Results are easy to obtain. Fingerstick sampling and a small sample size (40μL) makes results less painful and time consuming.

View Brochures, Videos & More at POR.io Enter Number 8747 in the Search Area

46 | PHYSICIANS OFFICE RESOURCE


8748


CLIA WAIVED FULL COMPLEMENT OF CLIA-WAIVED

PRODUCT FOCUS

Full Complement of CLIA-waived Blood Chemistry Tests BLOOD CHEMISTRY TESTS PICCOLO ® Chemistry Analyzer from Abbott Piccolo Xpress

XPRESS® CHEMISTRY ANALYZER

The PiccoloFrom Xpress Chemistry Analyzer provides physician offices with Abbott lab-accurate results for a broad range of CLIA-waived general chemistry The Piccolo Xpress Chemistry Analyzer provides physician tests, including metabolic panels, lipids, and kidney function, offices with lab-accurate results liver, for a broad range of CLIA- and more with just 100waived microliters blood. Easy use, themetabolic Piccolo Xpress generalofchemistry tests,toincluding panels, provides lipids, live, and visit, kidneyaccelerating function, andtreatment more with decisions, just 100 results during a patient’s increasing microliters of blood. EAsy to use, the PIccolo Xpress provides 8749 efficiency, and supporting patient satisfaction. Automated quality control on results during a patient’s visit, accelerating treatment decisions, every test helps ensure accuracy. increasing efficiency, and supporting patient satisfaction. Automated quality control on every test helps ensure accuracy. For in vitro diagnostic use only. This material is intended for a U.S. audience only. Piccolo Xpress is View a registered trademark of Abaxis, Inc. and by Abbott Point of Care. Brochures, Videos & distributed More at POR.io Physician Office Resource Piccolo Product Description – US 3065.REV1 08/20

Enter Number 8749 in the Search Area

LAB-ACCURATE RESULTS FOR ACR AND HBA1C

8750

From Abbott With its compact size and panel of tests, the Afinion 2 system is ideal for point-of-care testing in physician offices, clinics, community health centers and hospital out-patient clinics. From just a small urine or fingerstick whole blood sample, lab-accurate results for ACR and HbA1c are made available during the consultation.

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BD VERITOR™ PLUS SYSTEM From BD Veritor™

8751

The BD Veritor™ Plus System is a portable, easy-to-use, testing solution for SARS-COV-2*, Flu A+ B and other respiratory tract infections that delivers results in 15 minutes or less. It features two analysis modes that adapt to your workflow, online education tools, and optional reporting capabilities including the BD Synapsys™ Informatics Solution—making it the point-ofcare diagnostic tool you won’t want to be without. *EUA authorized by FDA

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48 | PHYSICIANS OFFICE RESOURCE


CLIA WAIVED

From BioFire The BioFire RP EZ accurately detects and identifies 14 viral and bacterial pathogens—not just Flu A and Flu B—so you can provide your patients with the right treatment, the first time. The test is easy and can be performed right in your office or clinic, with results in about an hour. The BioFire RP EZ is designed to run on a single computer/instrument configuration (EZ Configuration) of the BioFire® FilmArray® 2.0 System.

—

View Brochures, Videos & More at POR.io Enter Number 8752 in the Search Area

RELIABLE DETECTION OF STREP A, FLU A, FLU B AND RSV From Cepheid Cepheid’s GeneXpert Xpress® brings standardized molecular testing to any healthcare setting. Employing the highly accurate and easy to use lab in a cartridge technology in every GeneXpert system, the GeneXpert Xpress® is a true on-demand walkaway testing system that provides accurate and reliable detection of Strep A, Flu A, Flu B and RSV. Two or four-module configurations save valuable bench space and reduce the need for multiple testing platforms.

8753

View Brochures, Videos & More at POR.io Enter Number 8753 in the Search Area

ORAQUICK® HCV RAPID ANTIBODY TEST From OraSure

8754

The OraQuick® HCV Rapid Antibody Test is the FIRST and ONLY FDA-approved, point of care test for the detection of HCV antibodies. This CLIA-waived platform delivers an accurate diagnosis in 20 minutes. The test can be completed in 3 simple steps from fingerstick or venous whole blood with less than 2 minutes of hands on time. It is ideal for testing programs in both clinical and non-clinical settings, as well as outreach events.

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2021 · BUYERS GUIDE | 49

PRODUCT FOCUS

8752

CLIA-WAIVED BIOFIRE® FILMARRAY® RESPIRATORY PANEL (RP) EZ


PRODUCT FOCUS

CLIA WAIVED ORAQUICK ADVANCE® RAPID HIV-1/2 ANTIBODY TEST From OraSure 8755

The OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test is an FDAapproved point of care screening test for use with oral fluid, fingerstick or venous whole blood and plasma. The test delivers lab accurate results within 20 minutes with less than 2 minutes of hands on time. This simple test is ideal for testing programs in both clinical and non-clinical settings, as well as outreach events.

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ACUCY INFLUENZA A&B TEST From Sekisui Diagnostics The Acucy™ Influenza A&B Test is for the rapid, qualitative detection of influenza A and B viral nucleoprotein antigens from both nasal and nasopharyngeal swabs. Utilizing the Acucy™ Reader in either the point-of-care or laboratory setting, workflow flexibility is achieved with both Read Now and Walk Away features. The combination provides clinicians with standardized and definitive result interpretation.

8756

View Brochures, Videos & More at POR.io Enter Number 8756 in the Search Area

SILARIS™ INFLUENZA A&B TEST From Sekisui Diagnostics A molecular test utilizing polymerase chain reaction (PCR) technology providing accurate results for early diagnosis and proper management of influenza. Accurate √ Molecular Results √ State-of-the art microfluidic cassette technology √ PCR test using proprietary OscAR™ Technology Affordable √ Single Test Diagnosis √ Controls in every kit √ Molecular reimbursement (CPT Code 87502)

8757

Simple √ Easy to Use √ Compact portable dock with no calibration required √ Room temperature storage

View Brochures, Videos & Mores at POR.io Enter Number 8757 in the Search Area 50 | PHYSICIANS OFFICE RESOURCE


CLIA WAIVED OSOM ULTRA PLUS FLU A&B TEST From Sekisui Stronger Clinical Performance Takes Lateral Flow Testing To The Next Level. Providing superior rapid results at the point-of-care. Fast, easy, cost effective so you can test and treat in one visit. • High Performance- Equivalent or exceeding the performance of reader devices, without the need for an instrument • Results in 10 minutes • OSOM® Custom Care- Exceptional Support/Training by licensed medical technologists and experienced healthcare professionals • Made in the USA —

View Brochures, Videos & More at POR.io Enter Number 8758 in the Search Area

OSOM® BVBLUE® From Sekisui Diagnostics The OSOM® BVBLUE® detects elevated vaginal fluid sialidase activity, an enzyme produced by bacterial pathogens associated with bacterial vaginosis including Gardnerella, Bacteroides, Prevotella and Mobiluncus. OSOM® BVBLUE® is more sensitive than Amsel criteria providing physicians with a more accurate diagnosis to treat and minimize serious health consequences such as early spontaneous preterm births and miscarriage.

8759

View Brochures, Videos & More at POR.io Enter Number 8759 in the Search Area

8760

ULTRA HCG COMBO TEST From Sekisui Diagnostics The OSOM® Ultra hCG Combo test is a simple immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Internal studies have confirmed that the OSOM® Ultra hCG Combo test does not have a false negative result from hCG variants providing physicians with a higher level of confidence.

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2021 · BUYERS GUIDE | 51

PRODUCT FOCUS

8758


PRODUCT FOCUS

CLIA WAIVED

OSOM® TRICHOMONAS RAPID TEST From Sekisui Diagnostics

The OSOM® Trichomonas Rapid Test is intended for the qualitative detection of Trichomonas vaginalis antigens from vaginal swabs or from the saline solution. The OSOM® Trichomonas Rapid Test is the only CLIA-waived rapid test available today. OSOM® Trichomonas is more sensitive than wet mount due to the assay being able to detect viable and non-viable organisms which offers significant benefits to the patient and clinician alike.

8761

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OSOM® ULTRA STREP A TEST

From Sekisui Diagnostics

8762

The OSOM® Ultra Strep A test is a color immunochromatographic assay intended for the qualitative detection of Group A Streptococcus antigen directly from throat swab specimens. Shown to be not statistically different than single swab culture. Sensitivity 95.7% and 100% Specificity. Includes two additional test sticks for External QC. CLIA Waived..

View Brochures, Videos & More at POR.io Enter Number 8762 in the Search Area

8763

FIRST EVER CLIA WAIVED HEMATOLOGY ANALYZER From Sysmex Faster test results, clinical decisions and greater practice efficiency are coming to physicians’ offices with the first CLIA-waived CBC analyzer. Hematology diagnostics leader Sysmex is bringing more lab testing to the point of care. One of the most common blood tests can be conducted reliably and accurately on-site, in as few as three minutes. The device’s ease of use and innovative technology means in-house staff can operate it in just a few easy steps, without lengthy certification and training. The new Sysmex XW-100 will improve health care efficiency and patient care.

View Brochures, Videos & Mores at POR.io Enter Number 8763 in the Search Area 52 | PHYSICIANS OFFICE RESOURCE


COVID-19 TESTING From BD Veritor™

8764

The BD Veritor™ Plus System is a portable, easy-to-use, testing solution for SARS-COV-2*, Flu A+ B and other respiratory tract infections that delivers results in 15 minutes or less. It features two analysis modes that adapt to your workflow, online education tools, and optional reporting capabilities including the BD Synapsys™ Informatics Solution—making it the point-ofcare diagnostic tool you won’t want to be without. *EUA authorized by FDA

View Brochures, Videos & More at POR.io Enter Number 8764 in the Search Area

BIOFIRE® RESPIRATORY 2.1-EZ (RP2.1-EZ)1 PANEL (EUA)1

From BioFire

8765

SARS-CoV-2 is everyone’s top suspect, but many other respiratory bugs can cause similar, overlapping symptoms. In your clinic, you can test for 19 common respiratory pathogens, including SARS- CoV-2, with the BioFire RP2.1-EZ Panel (EUA)1—now available under an FDA Emergency Use Authorization. Syndromic testing means all it takes is one test and just 45 minutes to round up SARS-CoV-2—and all the other usual respiratory suspects. 1. This test is not FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories.

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FIRST EUA POINT-OF-CARE (POC/WAIVED/ FINGERSTICK) COVID-19 ANTIBODY TEST NOW AVAILABLE From Carolina Liquid Chemistries

8766

The Fastep® COVID-19 IgG/IgM Rapid Test Device by Assure Tech., distributed in the USA by Carolina Liquid Chemistries, has received FDA Emergency Use Authorization for use with fingerstick whole blood specimens at the point-of-care, i.e. in patient care settings operating under CLIA Certificate of Waiver such as doctor’s offices, hospitals, urgent care centers and emergency rooms rather than having to be sent to a central lab.Refer to carolinachemistries.com for instructions for use, fact sheets, FDA EUA letters, clinical performance studies, and material safety data sheets. Not FDA cleared; only for emergency use under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless authorization is terminated or revoked.

View Brochures, Videos & More at POR.io Enter Number 8766 in the Search Area 2021 · BUYERS GUIDE | 53

PRODUCT FOCUS

BD VERITOR™ PLUS SYSTEM


COVID-19 TESTING PRODUCT FOCUS

MEDICUS LIS From Medicus LIS

8767

If you are considering in-house lab testing, including Covid-19 testing and required reporting to state agencies, connecting Lab to LIS and EHR makes the process of test orders to completed results much easier. Providers receive test results posted to patient charts in real-time, expediting patient care, saving time, money and even preparing for lab test reimbursement goals. Link Your Lab with Medicus LIS today! Contact us: 888-643-8081 sales@medicuslis.com —

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CRYOSURGERY HISTOFREEZER® FLEX From CryoConcepts This canister-based devices is the latest advance in portable cryosurgery for the physician office. Its advanced design give doctors the option of using cones or buds to deliver the cryogen to the treatment site. There is no risk of cryogen splattering during treatment and our cryogen stays colder versus other products on the market which lead to better first time outcomes.

8768

—

View Brochures, Videos & More at POR.io Enter Number 8768 in the Search Area

CRYOLAB® MEDICAL From CryoConcepts

8769

CryoLab is a desk-top sized unit that delivers cryogen and employs pre-set spray times to ensure safe and effective treatment. Our lighted wand can spray the cryogen from any direction making it easier to treat all locations on the patient. CryoLab® can dispense nitrous oxide or carbon dioxide allowing physicians to treat cosmetically sensitive areas on the face, hands, and chest with less trauma and downtime. —

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54 | PHYSICIANS OFFICE RESOURCE


CRYOSURGERY

From CryoConcepts This pen-like device is the perfect choice when low entry costs, portability, and precise delivery are critical to the practice. CryOmega® dispenses nitrous oxide – the coldest portable cryogen and the pinpoint tip allow physicians to effective treat the lesion site without harming healthy tissue. —

8770

View Brochures, Videos & More at POR.io Enter Number 8770 in the Search Area

CRYOCLEAR® From CryoConcepts 8771

This is a new pen-like cryo devices that dispenses carbon dioxide which is perfect for superficial lesions such as sun spots, age spots, and shin tags. CryoClear® has enough gas to treat between 20 and 30 lesions depending on the size and type. —

View Brochures, Videos & More at POR.io Enter Number 8771 in the Search Area

DRUG TESTING TOXICOLOGY URINE DRUG SCREENING REAGENTS From Abbott 8772

Prescription drug misuse and illicit drug abuse is a growing public health challenge in this country. Building a test profile that covers highly misused drugs has never been so vital. With over 20 relevant assays to choose from Abbott’s suite of Immunalysis reagents allows you to easily screen for relevant substances. Our complete line of assays, calibrators, and controls enables you to implement an efficient drug screening program in office. —

View Brochures, Videos & More at POR.io Enter Number 8772 in the Search Area

2021 · BUYERS GUIDE | 55

PRODUCT FOCUS

CRYOMEGA®


PRODUCT FOCUS

DRUG TESTING

8773

Toxicology Screening Simplified Abbott’s ImmTox 270 Benchtop Analyzer Now with 14 assays CLIA Categorized as Moderate Complexity From Abbott The ImmTox270 benchtop analyzer offers comprehensive toxicology screening solutions for physician offices, treatment centers and independent laboratories. Broad test menu with over 20 assays to choose from including 14 that are now available as moderately complex. With complete laboratory solutions from consultation to licensure, and compliance the Abbott Clinical Laboratory Solutions team has you covered.

View Brochures, Videos & More at POR.io Enter Number 8773 in the Search Area

EXAM ROOM EQUIPMENT

THE BREWER BASIC EXAM TABLE From Brewer Full featured, entry-level exam table design. The Brewer Basic Exam Table features a pneumatic cylinder, seamless upholstery, and the largest storage capacity available. We invite you to compare features, price, warranty and you will find the Brewer Basic Exam Table is clearly the best entry level exam table available.

8774

View Brochures, Videos & More at POR.io Enter Number 8774 in the Search Area

8775

BREWER’S ACCESS™ HIGH-LOW EXAM TABLE From Brewer Design provides an 18” profile in the seated position to allow level transfer from standard wheelchair heights, complete with upright seat back and safety grab bars to simplify reliable patient transfers. The system also offers abundant storage capacity with Brewer’s signature pass-through drawer system and it is backed by Brewer’s standard 3-year warranty.

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56 | PHYSICIANS OFFICE RESOURCE


EXAM ROOM EQUIPMENT 8776

From Brewer Step up to power table performance for less with Brewer’s Flex™ Access Exam Table. Industry-leading 700-lb. patient weight capacity, unique safety features and unmatched ergonomic patient access maximize your clinical efficiency and ROI. A streamlined footprint and optional upgrades like safety grab bars, stirrups, and pass-through work surface provide ultimate flexibility for your practice.

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FLU TESTING BD VERITOR™ PLUS SYSTEM From BD Veritor™ The BD Veritor™ Plus System is a portable, easy-to-use, testing solution for SARS-COV-2*, Flu A+ B and other respiratory tract infections that delivers results in 15 minutes or less. It features two analysis modes that adapt to your workflow, online education tools, and optional reporting capabilities including the BD Synapsys™ Informatics Solution—making it the point-ofcare diagnostic tool you won’t want to be without.

8777

*EUA authorized by FDA

View Brochures, Videos & More at POR.io Enter Number 8777 in the Search Area

CLIA-WAIVED BIOFIRE® FILMARRAY® RESPIRATORY PANEL (RP) EZ 8778

From BioFire The BioFire RP EZ accurately detects and identifies 14 viral and bacterial pathogens—not just Flu A and Flu B—so you can provide your patients with the right treatment, the first time. The test is easy and can be performed right in your office or clinic, with results in about an hour. The BioFire RP EZ is designed to run on a single computer/instrument configuration (EZ Configuration) of the BioFire® FilmArray® 2.0 System.

—

View Brochures, Videos & More at POR.io Enter Number 8778 in the Search Area 2021 · BUYERS GUIDE | 57

PRODUCT FOCUS

BREWER’S FLEX™ ACCESS EXAM TABLE


PRODUCT FOCUS

FLU TESTING ACUCY INFLUENZA A&B TEST From Sekisui Diagnostics 8779

The Acucy™ Influenza A&B Test is for the rapid, qualitative detection of influenza A and B viral nucleoprotein antigens from both nasal and nasopharyngeal swabs. Utilizing the Acucy™ Reader in either the point-of-care or laboratory setting, workflow flexibility is achieved with both Read Now and Walk Away features. The combination provides clinicians with standardized and definitive result interpretation.

View Brochures, Videos & More at POR.io Enter Number 8779 in the Search Area

SILARIS™ INFLUENZA A&B TEST From Sekisui Diagnostics A molecular test utilizing polymerase chain reaction (PCR) technology providing accurate results for early diagnosis and proper management of influenza. Accurate √ Molecular Results √ State-of-the art microfluidic cassette technology √ PCR test using proprietary OscAR™ Technology Affordable √ Single Test Diagnosis √ Controls in every kit √ Molecular reimbursement (CPT Code 87502) Simple √ Easy to Use √ Compact portable dock with no calibration required √ Room temperature storage

8780

View Brochures, Videos & Mores at POR.io Enter Number 8780 in the Search Area

OSOM ULTRA PLUS FLU A&B TEST 8781

From Sekisui Stronger Clinical Performance Takes Lateral Flow Testing To The Next Level. Providing superior rapid results at the point-of-care. Fast, easy, cost effective so you can test and treat in one visit. • High Performance- Equivalent or exceeding the performance of reader devices, without the need for an instrument • Results in 10 minutes • OSOM® Custom Care- Exceptional Support/Training by licensed medical technologists and experienced healthcare professionals • Made in the USA —

View Brochures, Videos & More at POR.io Enter Number 8781 in the Search Area 58 | PHYSICIANS OFFICE RESOURCE


FOBT PRODUCT FOCUS

CLIA-WAIVED OSOM® IFOB From Sekisui Diagnostics

8782

The CLIA-waived OSOM® iFOB test gives the physician and the patient a simpler, more compliant colon cancer screening option that is highly accurate and specific to human hemoglobin. With the ability of a convenient take home kit, patients can collect in the privacy of their own home with no dietary or drug restrictions in just one sample increasing the physician compliance for yearly screening.

View Brochures, Videos & More at POR.io Enter Number 8782 in the Search Area

GLUCOSE TESTING ACCURATE, ACTIONABLE RESULTS FROM THE LEADER IN POINT-OFCARE LIPID TESTING From Abbott The CLIA-waived Alere Cholestech LDX™ Analyzer is engineered for confidence, providing accurate, actionable, and readily accessible results that have set the standard in point-of-care lipid profile, cholesterol, and glucose testing. Results are easy to obtain. Fingerstick sampling and a small sample size (40μL) makes results less painful and time consuming.

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8783

HbA1c

8784

LAB-ACCURATE RESULTS FOR ACR AND HBA1C From Abbott With its compact size and panel of tests, the Afinion 2 system is ideal for point-of-care testing in physician offices, clinics, community health centers and hospital out-patient clinics. From just a small urine or fingerstick whole blood sample, lab-accurate results for ACR and HbA1c are made available during the consultation.

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2021 · BUYERS GUIDE | 59


HEMATOLOGY ANALYZERS PRODUCT FOCUS

EASY, INTEGRATED WITH-PATIENT SYSTEM Easy, TESTING IntegratedI-STAT With-Patient Testing From Point of Care at Abbott i-STAT System from Point of Care at Abbott The handheld i-STAT System offers a broad menu of diagnostic tests

at the patient’s side inSystem just minutes. Witha just a few drops of of blood, The handheld i-STAT offers broad menu diagnostic tests at th the i-STAT System delivers real time, lab-accurate results for a wide patient’s side in just minutes. With just a few drops of blood, the i-STAT range of tests, including chemistries, blood gas, coagulation, cardiac markers, and more. delays and wasted time with System delivers real Minimize time, lab-accurate results foron-side a wide range of tests, tests. Easy, intuitive operation. including chemistries, blood gas, coagulation, cardiac markers, and more. 8785 For intended andwasted completetime product information, pointofMinimize delaysuse and with on-site visit tests. Easy, intuitive operatio care.abbott.

For intended use and complete product information, visit pointofcare.abbott. For in vitro diagnostic use only. This material is intended for a U.S.

For in vitro diagnostic usei-STAT only. This is intended for a U.S. audience only.Reaudience only. is amaterial trademark of Abbott. Physician Office i-STAT issource a trademark of Abbott. Physician Office—Resource i-STAT Product i-STAT Product Description US 3064.REV1 08/20 Description – US 3064.REV1 08/20

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TURN SMALL PLACES INTO SMART SPACES From Abbott

8786

With reduced budgets, shrinking laboratory space and staffing challenges, many laboratories need a solution that lets them work smarter with less. The CELL-DYN Emerald 22 AL is a full performance, automated optical 5-part differential analyzer that delivers smarter results for small to midsize clinical laboratories. • Compact Design • Walkaway Functionality • Ease Of Use • Smart Safety Features

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CELL-DYN EMERALD HEMATOLOGY ANALYZER From Abbott

8787

CELL-DYN Emerald is a 3-part differential hematology analyzer that offers high performance in an affordable, compact design that provides reliable and accurate patient results every time. As a smaller operating laboratory, you need a solution that offers reliable results. CELL-DYN Emerald provides results in under 65 seconds. CELL-DYN Emereald’s small size, simple touch screen software and reliability offer an easy-to-use, truly compact table/bench top instrument for easy performance in your laboratory.

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HEMATOLOGY ANALYZERS

From ALCOR Scientific miniiSED™ is the newest of the iSED® family of ESR analyzers from ALCOR Scientific. The miniiSED™ measurement of ESR is accurate and unaffected by variables associated with traditional methodologies, such as hematocrit. This single position, fully automated ESR analyzer works directly from primary EDTA tubes, requires 100 μL of sample, has an internal barcode reader, and produces results in 15 seconds! miniiSED™ is the ideal solution to ESR testing for small laboratories, POL’s, and emergency clinics. Proudly manufactured in the USA.

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MICROS HEMATOLOGY ANALYZER WITH 3-PART DIFFERENTIAL PLUS THE LITEDM

8789

From HORIBA Medical Is it viral or bacterial? A CBC with 3-part differential can provide the clues to help distinguish between viral and bacterial infections before you decide to treat. The Micros 60 Hematology analyzer provides a CBC with 3-part Diff result in less than 60 seconds using only 10 µL of sample. Connect to the LiteDM Patient Data Management System for an affordable way to consolidate patient results to one report.

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8790

PENTRA 60 C+ HEMATOLOGY ANALYZER WITH 5-PART DIFFERENTIAL From HORIBA Medical Now you can have the same results hospitals and reference labs provide in a small, benchtop analyzer. The Pentra 60 C+ hematology analyzer provides a CBC with 5-part differential result using proprietary technology that ensures an accurate count and differential on the first run. Reduce repeats and reflex to the microscope with Pentra hematology technology.

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61 | PHYSICIANS OFFICE RESOURCE

2021 · BUYERS GUIDE | 61

PRODUCT FOCUS

8788

MINÍÍMIZE THE HASSLE OF ESR TESTING IN YOUR LAB


PRODUCT FOCUS

HEMATOLOGY ANALYZERS MICROS ES 60 HEMATOLOGY ANALYZER WITH 3-PART DIFFERENTIAL From HORIBA Medical Simple to use and easy to maintain with a zero maintenance concept, the Micros ES 60 is a small tabletop hematology analyzer with an integrated data management system. The analyzer provides a CBC with 3-part differential result in less than 60 seconds using only 10 µL of sample. Connect to the LiteDM Patient Data Management System for an affordable way to consolidate patient results to one report.

8791

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PENTRA XLR HEMATOLOGY ANALYZER WITH 5-PART DIFFERENTIAL

8792

From HORIBA Medical The Pentra XLR hematology analyzer with autoloader provides a CBC with 5-part Diff result using proprietary technology that ensures an accurate count and differential on the first run. The Pentra XLR also provides a complete menu of Retic parameters for treating oncology and anemia patients. The autoloader processes 80 samples an hour and provides random continuous access for mediumto high-volume clinics and rural or community hospitals.

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8793

FIRST EVER CLIA WAIVED HEMATOLOGY ANALYZER From Sysmex Faster test results, clinical decisions and greater practice efficiency are coming to physicians’ offices with the first CLIA-waived CBC analyzer. Hematology diagnostics leader Sysmex is bringing more lab testing to the point of care. One of the most common blood tests can be conducted reliably and accurately on-site, in as few as three minutes. The device’s ease of use and innovative technology means in-house staff can operate it in just a few easy steps, without lengthy certification and training. The new Sysmex XW-100 will improve health care efficiency and patient care.

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HEMATOLOGY ANALYZERS

From Sysmex 8794

Designed for labs testing up to 25 samples per day, the Sysmex pocH-100i™ has the smallest footprint of any analyzer on the market. The instrument requires only 15uL of whole blood for reporting of 17 clinical parameters, including a 3-part WBC Differential. It is ideal for urgent care, physician office lab, small clinic, or any outpatient setting where a point of care CBC is needed.

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SYSMEX XN-L™ SERIES AUTOMATED HEMATOLOGY ANALYZERS From Sysmex Now lower volume customers can enjoy the same capabilities in CBC testing as larger hospitals and reference labs. Enhanced clinical value is standard and optional licenses for reticulocyte or body fluid testing are available. The XN-L analyzers are the first to feature BeyondCareSM Quality Monitor, an innovative, webbased QC and calibration management program.

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8795

NOW IT’S MORE THANK JUST A BLOOD TEST From Sysmex With its simplified operation, the Sysmex XP-300™ is ideal for clinics and physician office labs. It provides a CBC with 17 different parameters, including a 3-part WBC Differential. The XP300+M combines the accuracy and reliability of a Sysmex CBC with the agility of Medicus Middleware. Features include EMR connectivity, instrument interfaces and a QC module.

8796

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2021 · BUYERS GUIDE | 63

PRODUCT FOCUS

HEMATOLOGY TESTING MADE EASY


PRODUCT FOCUS

IMMUNOASSAY ANALYZERS FULLY AUTOMATED QUANTITIVE IMMUNOASSAY ANALYZER

8797

From Sekisui Diagnostics The FastPack® IP System is a fully automated quantitative immunoassay analyzer designed for use in the Physician Office laboratory. Utilizing sophisticated chemiluminescence technology, the FastPack® IP System provides the capability to produce complex immunoassay results in 12 minutes or less with a push of a button. Menu includes Vitamin D, Testosterone, TSH, Free T4 PSA and hCG.

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THE NANOENTEK FREND IMMUNOASSAY SYSTEM From NanoEnTek The NanoEnTek FREND Immunoassay System provides Vitamin D, TSH, fT4, PSA, and Testosterone results in minutes with a no cost placement program. Complete all 5 tests in less than 20 minutes for same visit patient consultation. PSA and TSH results are available in 3 minutes or less. Imagine having a new source of revenue with improved practice efficiency and patient satisfaction. Thoughtfully designed, with your practice in mind.

8798

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LABORATORY SERVICES MEDICUS LIS 8799

From Medicus LIS If you are considering in-house lab testing, including Covid-19 testing and required reporting to state agencies, connecting Lab to LIS and EHR makes the process of test orders to completed results much easier. Providers receive test results posted to patient charts in real-time, expediting patient care, saving time, money and even preparing for lab test reimbursement goals. Link Your Lab with Medicus LIS today! Contact us: 888-643-8081 sales@medicuslis.com —

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64 | PHYSICIANS OFFICE RESOURCE


LABORATORY SERVICES

From My Inspection Make laboratory compliance and inspections easier by changing how you document, save and retrieve all information necessary to meet CLIA and accreditation regulations. With two unique electronic tools My Compliance Manual and MyInspection™ Software, the guesswork and tedious task of interpreting and documenting policy, procedure, forms, charts and logs is over. Your lab will be compliant, have less paper, and be inspection ready.

8800

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LIPID TESTING ACCURATE, ACTIONABLE RESULTS FROM THE LEADER IN POINT-OFCARE LIPID TESTING From Abbott The CLIA-waived Alere Cholestech LDX™ Analyzer is engineered for confidence, providing accurate, actionable, and readily accessible results that have set the standard in point-of-care lipid profile, cholesterol, and glucose testing. Results are easy to obtain. Fingerstick sampling and a small sample size (40μL) makes results less painful and time consuming.

8801

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PULSE OXIMETRY PRONTO® PULSE CO-OXIMETER® From Masimo

8802

Pronto® Pulse Co-Oximemter® with rainbow® Technology for Noninvasive Spot-Checking of Total Hemoglobin (SpHb®) and Sp02 in a Handheld device. Featuring Masimo SET® Measure-through Motion and Low Perfusion™ Pulse Oximetry Technology: > Helps clinicians monitor more than 100 million patients a year1 >Used by the top 10 U.S. hopitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll2 1 Estimate: Masimo data on file. 2 http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals- honor-roll-and-overview

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2021 · BUYERS GUIDE | 65

PRODUCT FOCUS

MAKE LABORATORY COMPLIANCE AND INSPECTION EASIER


PRODUCT FOCUS

PULSE OXIMETRY

RAD-97™ PULSE CO-OXIMETER® From Masimo

8803

Rad-97™ Pulse CO-Oximeter® with Integrated Noninvasive Blood Pressure (NIBP) in a Standalone Bedside device >Upgradable rainbow SET™ Measurements allow for continuous monitoring of multiple additional parameters > Customizable display allows for quick assessment of patient status > Configurable patient profile settings for a variety of patient populations > Connectivity Solutions for electronic charting of patient data

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REAGENTS TOXICOLOGY URINE DRUG SCREENING REAGENTS From Abbott Prescription drug misuse and illicit drug abuse is a growing public health challenge in this country. Building a test profile that covers highly misused drugs has never been so vital. With over 20 relevant assays to choose from Abbott’s suite of Immunalysis reagents allows you to easily screen for relevant substances. Our complete line of assays, calibrators, and controls enables you to implement an efficient drug screening program in office.

8804

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RSV TESTING BD VERITOR™ PLUS SYSTEM From BD Veritor™

8805

The BD Veritor™ Plus System is a portable, easy-to-use, testing solution for SARS-COV-2*, Flu A+ B and other respiratory tract infections that delivers results in 15 minutes or less. It features two analysis modes that adapt to your workflow, online education tools, and optional reporting capabilities including the BD Synapsys™ Informatics Solution—making it the point-ofcare diagnostic tool you won’t want to be without. *EUA authorized by FDA

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66 | PHYSICIANS OFFICE RESOURCE


RSV TESTS

From BioFire The BioFire RP EZ accurately detects and identifies 14 viral and bacterial pathogens—not just Flu A and Flu B—so you can provide your patients with the right treatment, the first time. The test is easy and can be performed right in your office or clinic, with results in about an hour. The BioFire RP EZ is designed to run on a single computer/instrument configuration (EZ Configuration) of the BioFire® FilmArray® 2.0 System.

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BIOFIRE® FILMARRAY® TORCH From BioFire The BioFire® FilmArray® Torch is a fully integrated, random, and continuous access system designed to meet your laboratory’s syndromic infectious disease testing needs. The BioFire Torch offers a radically reduced benchtop footprint, saving precious space in the lab, and its scalability meets high throughput demands. BioFire® FilmArray® Link Software automatically uploads patient results. Fully compatible with all CLIA Moderate BioFire® FilmArray® Panels, the BioFire Torch helps you maximize efficiency and productivity.

8807

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8808

THE SILARIS® RSV TEST From Sekisui Diagnostics The Silaris® RSV Test is a molecular diagnostic test utilizing polymerase chain reaction (PCR) technology providing accurate results to aid in early diagnosis and proper management of RSV. The system is easy to use, compact, portable and CLIA Waived so you can test and treat in one visit.

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2021 · BUYERS GUIDE | 67

PRODUCT FOCUS

8806

CLIA-WAIVED BIOFIRE® FILMARRAY® RESPIRATORY PANEL (RP) EZ


RSV TESTS PRODUCT FOCUS

RELIABLE DETECTION OF STREP A, FLU A, FLU B AND RSV From Cepheid Cepheid’s GeneXpert Xpress® brings standardized molecular testing to any healthcare setting. Employing the highly accurate and easy to use lab in a cartridge technology in every GeneXpert system, the GeneXpert Xpress® is a true on-demand walkaway testing system that provides accurate and reliable detection of Strep A, Flu A, Flu B and RSV. Two or four-module configurations save valuable bench space and reduce the need for multiple testing platforms.

8809

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SPIROMETRY MICRO 1 SPIROMETER From MicroDirect Specifically designed for situations where low cost precision spirometry measurements are required, the Micro I Spirometer measures the following parameters FEV1, FVC, PEF, FEF25-75, EEV6, FEV1/FVC, FEV1/FEV6, FEF25 and FEF25 that cn be displayed along with percent predicted and post bronchodilator comparisons and provide an optional printout if needed. Extremely lightweight and portable making it suitable for hospital outreach clinics, bedside screenings, health fair screenings and other situations where remote testing is required.

8810

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SPIROMETRY IS EASY From MicroDirect Unless the equipment is easy to use, it will not be fully utilized by your staff. The MicroLab and MicroLoop are menu driven via a large graphic display and the test takes less than five minutes to perform. The easy-to-read reports, quality checks and built-in interpretation assist with your diagnosis. Your office sees patients with indications for spirometry on a daily basis. Accurately and quickly diagnosis them so you can properly treat them.

8811 68 | PHYSICIANS OFFICE RESOURCE

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SPIROMETRY

8812

PRODUCT FOCUS

PORTABLE, SINGLE CLICK OPERATION SPIROMETER From MicroDirect The MicroDirect SpiroUSB many features include single click operation of all main functions, full ATS/ERS test quality checks, real time Flow/Volume and Volume/ Time traces, a choice of child incentive displays, choice of predicted values, estimated lung age, pre/post bronchodilator comparisons and can be used on multiple PC’s with dongle software protection key. The child incentive display and ATS quality checks ensure maximal results every time. Use with a laptop for true portability.

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STI ORAQUICK® HCV RAPID ANTIBODY TEST From OraSure The OraQuick® HCV Rapid Antibody Test is the FIRST and ONLY FDA-approved, point of care test for the detection of HCV antibodies. This CLIA-waived platform delivers an accurate diagnosis in 20 minutes. The test can be completed in 3 simple steps from fingerstick or venous whole blood with less than 2 minutes of hands on time. It is ideal for testing programs in both

8813

clinical and non-clinical settings, as well as outreach events.

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ORAQUICK ADVANCE® RAPID HIV-1/2 ANTIBODY TEST From OraSure 8814

The OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test is an FDAapproved point of care screening test for use with oral fluid, fingerstick or venous whole blood and plasma. The test delivers lab accurate results within 20 minutes with less than 2 minutes of hands on time. This simple test is ideal for testing programs in both clinical and non-clinical settings, as well as outreach events.

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STREP TESTS PRODUCT FOCUS

BD VERITOR™ PLUS SYSTEM From BD Veritor™ The BD Veritor™ Plus System is a portable, easy-to-use, testing solution for SARS-COV-2*, Flu A+ B and other respiratory tract infections that delivers results in 15 minutes or less. It features two analysis modes that adapt to your workflow, online education tools, and optional reporting capabilities including the BD Synapsys™ Informatics Solution—making it the point-ofcare diagnostic tool you won’t want to be without.

8815

*EUA authorized by FDA

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RELIABLE DETECTION OF STREP A, FLU A, FLU B AND RSV From Cepheid Cepheid’s GeneXpert Xpress® brings standardized molecular testing to any healthcare setting. Employing the highly accurate and easy to use lab in a cartridge technology in every GeneXpert system, the GeneXpert Xpress® is a true on-demand walkaway testing system that provides accurate and reliable detection of Strep A, Flu A, Flu B and RSV. Two or four-module configurations save valuable bench space and reduce the need for multiple testing platforms.

8816

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8817

OSOM® ULTRA STREP A TEST From Sekisui Diagnostics

The OSOM® Ultra Strep A test is a color immunochromatographic assay intended for the qualitative detection of Group A Streptococcus antigen directly from throat swab specimens. Shown to be not statistically different than single swab culture. Sensitivity 95.7% and 100% Specificity. Includes two additional test sticks for External QC. CLIA Waived..

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70 | PHYSICIANS OFFICE RESOURCE


TELEMEDICINE

From MedPod

8818

The Medpod Medical Cart optimizes productivity and load balancing by enabling access to remote physicians during high volume periods or to reach low-density populations. Medpod’s proprietary software integrates with a wide range of professional medical devices and gives the remote provider control of the devices to conduct an examination that is on par with a faceto-face visit. Patient images, audio and data can be captured, annotated, tagged and uploaded in real-time or stored and forwarded into the EHR by either remote or local provider.

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DEFINING MOBILE TELEDIAGNOSTICS From MedPod With the ability to deploy into a medical office in less than 2 minutes, MobileDoc is the ultimate portable practice. Revolutionary in its compact and mobile design, MobileDoc integrates best-in-class professional medical-grade devices with state-of-the-art HD video and EHR connectivity. Physicians can provide care remotely that is on par or better than a face-to-face visit, including conducting basic exams, checking vitals, and performing specialty testing— shattering the boundaries of traditional care.

8819

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URINALYSIS 8820

LAB-ACCURATE RESULTS FOR ACR AND HBA1C From Abbott With its compact size and panel of tests, the Afinion 2 system is ideal for point-of-care testing in physician offices, clinics, community health centers and hospital out-patient clinics. From just a small urine or fingerstick whole blood sample, lab-accurate results for ACR and HbA1c are made available during the consultation.

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2021 · BUYERS GUIDE | 71

PRODUCT FOCUS

OPTIMIZE PRODUCTIVITY AND EXPAND YOUR PRACTICE


Round up SARS-CoV-2 and 18 other pathogens. The new BioFire® Respiratory 2.1-EZ (RP2.1-EZ) Panel1 covers COVID-19 detection in your clinic. SARS-CoV-2 is everyone’s top suspect, but many other respiratory bugs can cause similar, overlapping symptoms. In your clinic, you can test for 19 common respiratory pathogens, including SARSCoV-2, with the BioFire RP2.1-EZ Panel—now available under an FDA Emergency Use Authorization.1.2 Syndromic testing means all it takes is one test and about 45 minutes to round up SARS-CoV-2—and all the other usual respiratory suspects. Rapid answers on a broad range of pathogens can inform patient management and alleviate patients and staff alike. What’s your frontline solution into respiratory season and beyond?

8821

1. This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection and differentiation of nucleic acid of SARS-CoV-2 from multiple respiratory viral and bacterial organisms. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. 2. For use with the CLIA-waived BioFire® FilmArray® 2.0 EZ configuration.

BFR0001-0517-01

To learn more, visit biofiredx.com


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