C O M P A N Y O V E R V I E W
PAML
- Pathology Associates Medical Laboratories
With a focus in diagnostics with national corporate headquarters in Washington, PAML is a recognized leader delivering healthcare solutions. Written by: Stephanie C. Ocano Produced by: Tom Venturo
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PAML Lab
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PAML General Administration
Our goal is to do anything and everything to help you as a provider to succeed in delivering the highest quality of care. This is the ideology behind PAML (Pathology Associates Medical Laboratories) – a medical reference laboratory serving physicians, hospitals and allied health professionals. Ranked among the top clinical reference laboratories in the nation and considered an industry leader in joint venture partnerships, PAML is dedicated to personalized service, rapid turnaround time and innovative information management systems.
We recently spoke with Dr. Francisco R. Velázquez, President and Chief Executive Officer at PAML, to further understand the history of the company and his methodology to become a driving force in the healthcare solutions industry. From West to East – A History of Going Nationwide Founded in 1957 in the town of Spokane, Washington, PAML was initially focused on serving the Pacific Northwest region. From Montana to Idaho, the company soon discovered that its reach could extend much farther. Over the years, w w w. p a m l . c o m
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BreathTek® UBT for H. pylori
You Suspected H. pylori. BreathTek UBT Confirmed.
To be sure of your diagnosis AND confirm treatment success, choose BreathTek UBT • Antibiotic resistance is approaching 25%, increasing the need for eradication confirmation1-3 • ACG* calls the UBT method “the most reliable nonendoscopic test…“ to confirm H. pylori eradication4 • BreathTek UBT offers excellent sensitivity (96%) and specificity (96%) to confirm eradication in adult patients5 • False negative test results may be caused by: − Ingestion of proton pump inhibitors (PPIs) within 2 weeks prior to performing the BreathTek UBT. If a negative result is obtained from a patient ingesting a PPI within 2 weeks prior to the BreathTek UBT, it may be a false-negative result and the test should be repeated 2 weeks after discontinuing the PPI treatment. A positive result for a patient on a PPI could be considered positive and be acted upon − Ingestion of antimicrobials or bismuth preparations within 2 weeks prior to performing the BreathTek UBT − Premature POST-DOSE breath collection time for a patient with a marginally positive BreathTek UBT result − Post-treatment assessment with the BreathTek UBT less than 4 weeks after completion of treatment for the eradication of H. pylori • False positive test results may be caused by urease associated with other gastric spiral organisms observed in humans, such as Helicobacter heilmannii or achlorhydria.
H. pylori can’t hide from BreathTek UBT… Approved as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults and children ages 3 to 17 years Please see BRIEF SUMMARY on adjacent page. Click here to learn more or visit BreathTek.com. *ACG, American College of Gastroenterology. April 2015
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Brief Summary about BreathTek UBT Intended Use The BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adult patients and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment if used at least 4 weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples, in clinical laboratories or point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results. The BreathTek UBT Kit is for administration by a health care professional, as ordered by a licensed health care practitioner. Warnings and Precautions • For in vitro diagnostic use only. The Pranactin®-Citric solution is taken orally as part of the diagnostic procedure and contains Phenylalanine (one of the protein components of Aspartame), 84 mg per dosage unit, and should be used with caution in diabetic patients. (For reference, 12 ounces of typical diet cola soft drinks contain approximately 80 mg of Phenylalanine.) • A negative result does not rule out the possibility of H. pylori infection. False negative results do occur with this procedure. If clinical signs are suggestive of H. pylori infection, retest with a new sample or an alternate method. • False negative test results may be caused by: — Ingestion of proton pump inhibitors (PPIs) within 2 weeks prior to performing the BreathTek UBT. If a negative result is obtained from a patient ingesting a PPI within 2 weeks prior to the BreathTek UBT, it may be a false-negative result and the test should be repeated 2 weeks after discontinuing the PPI treatment. A positive result for a patient on a PPI could be considered positive and be acted upon. — Ingestion of antimicrobials, or bismuth preparations within 2 weeks prior to performing the BreathTek UBT — Premature POST-DOSE breath collection time for a patient with a marginally positive BreathTek UBT result — Post-treatment assessment with the BreathTek UBT less than 4 weeks after completion of treatment for the eradication of H. pylori. • False positive test results may be caused by urease associated with other gastric spiral organisms observed in humans such as Helicobacter heilmannii or achlorhydria. • If particulate matter is visible in the reconstituted Pranactin-Citric solution after thorough mixing, the solution should not be used. • Patients who are hypersensitive to mannitol, citric acid or Aspartame should avoid taking the drug solution as this drug solution contains these ingredients. Use with caution in patients with difficulty swallowing or who may be at high risk of aspiration due to medical or physical conditions. • No information is available on use of the Pranactin-Citric solution during pregnancy. • For pediatric test results, the Urea Hydrolysis Rate (UHR) results must be calculated. The Delta over Baseline (DOB) results are only used to calculate the UHR metrics to determine H. pylori infection in pediatric patients. DOB results cannot be used to determine the infection status of pediatric patients. Use the web-based pUHR-CA (https://BreathTekKids.com) to calculate the UHR. • Safety and effectiveness has not been established in children below the age of 3 years. Adverse Events During post-approval use of the BreathTek UBT in adults, the following adverse events have been identified: anaphylactic reaction, hypersensitivity, rash, burning sensation in the stomach, tingling in the skin, vomiting and diarrhea. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to establish a causal relationship to drug exposure. In two clinical studies conducted in 176 (analyzed) pediatric patients ages 3 to 17 years to determine the initial diagnosis and post treatment monitoring of H. pylori, the following adverse events experienced by ≥1% of these patients were: vomiting (5.1%), oropharyngeal pain (4.5% to include throat irritation, sore throat, throat burning), nausea (2.3%), restlessness (2.3%), stomach ache/belly pain (1.1%), and diarrhea (1.1%). Most of the adverse events were experienced by patients within minutes to hours of ingestion of the Pranactin-Citric solution. In another clinical study comparing the UBiT®-IR300 and POCone® in pediatric patients ages 3 to 17 years, the following adverse events were observed among the 99 subjects enrolled: 2 incidences of headache, and 1 incidence each of cough, dry mouth and acute upper respiratory infection. May 2014
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References: 1. Vakil N, Megraud F. Eradication therapy for Helicobacter pylori. Gastroenterology. 2007;133(3):985-1001. 2. Vakil N, Fendrick AM. How to test for Helicobacter pylori in 2005. Cleve Clin J Med. 2005;72(suppl 2):S8-S13. 3. Chu Y-T, Wang Y-H, Wu J-J, Lei H-Y. Invasion and multiplication of Helicobacter pylori in gastric epithelial cells and implications for antibiotic resistance. Infect Immun. 2010;78(10):4157-4165. 4. Chey WD, Wong BCY; Practice Parameters Committee of the American College of Gastroenterology. American College of Gastroenterology guideline on the management of Helicobacter pylori infection. Am J Gastroenterol. 2007;102(8):1808-1825. 5. Package Insert for BreathTek UBT. Otsuka America Pharmaceutical, Inc; 2014.
©2015 Otsuka America Pharmaceutical, Inc.
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PA M L PAML grew to encompass a wider geographical presence, additionally realigning its focus to diagnostics. “About three years ago, we launched a professional services corporation,” said Dr. Velázquez. “We developed a portfolio of complementary skills that are useful not only to us as a company but more importantly bring valuable services to those that we work with.” Referring to PAML as a healthcare solutions company, Dr. Velázquez went on to explain that his primary goal was to do the best work possible, leaving his clients and partners with the solutions and a roadmap to providing better care. “Our goal is to go in and help you and leave as quickly as we can,” said Dr. Velázquez. Successful Direction How does a company remain competitive, especially within the
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healthcare industry? According to Dr. Velázquez, the answer is simple: pay attention. “We pay attention to new developments,” clarified Dr. Velázquez. “And not just in the healthcare industry, but in others as well.” “It’s important for us to understand what the world around us is doing because ultimately most of the trends that we see in other industries will come to healthcare,” he continued. PAML also connects with higher level academic institutions to understand where innovation is headed. By spending time with entrepreneurs and those investing venture capital dollars in new technologies, PAML successfully keeps its “finger on the pulse.” Innovative Solutions PAML is striving to close the gap in
“It’s important for us to understand what the world around us is doing because ultimately most of the trends that we see in other industries will come to healthcare” – Dr. Francisco R. Velázquez, President and Chief Executive Officer w w w. p a m l . c o m
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Sarstedt - solutions for the clinical lab Sarstedt offers modular technology for efficient sample preparation. With options for bulk loading, identification, decapping, sorting, aliquoting, and recapping - we provide the automation you need now plus the ability to add more later. And because we are also a global manufacturer of premium consumables, we can provide the total solution for all of your requirements. Sarstedt is a proud business partner of Pathology Associates Medical Laboratories.
800-257-5101 . customerservice@sarstedt.us . www.sarstedt.com
QUANTA Lite®
Calprotectin Differentiate between IBS and IBD with a non-invasive marker of intestinal inflammation.
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Now available, an FDA cleared assay that delivers the results physicians need for patients with symptoms of IBD • A new fecal ELISA test kit offering expanded dynamic range of 15.6-500mg/kg1 • High sensitivity helps guide decision-making when selecting patients for endoscopy2
For more information visit www.inovadx.com Scan this QR code or go to www.inovadx.com/calprotectin to learn more about this important marker
INOVA Diagnostics, Inc., San Diego, CA 92131 858-586-9900 www.inovadx.com References: 1. QUANTA Lite Calprotectin directional insert. 2. Bunn, S. et al. Fecal calprotectin: validation as a noninvasive measure of bowel inflammation in childhood inflammatory bowel disease. J Pediatric Gastroenterology Nutrition 2001;33:14-22.
QUANTA Lite is a trademark of Inova Diagnostics, Inc. © 2015 Inova Diagnostics, Inc. All rights reserved. 690416 August 2014 Rev. 1
PA M L the continuum of care between the time that individuals are consumers and the time that they are patients. “Right now, both worlds don’t connect and we’re looking to connect those better,” said Dr. Velázquez. With more consumers looking for ways to proactively manage their health, many have turned to the internet for help in accessing medical resources to help them make smart decisions. In response to this, late last year PAML unveiled its website for Cinch™, the company’s new consumerbased product line that empowers individuals to reveal their health through easy access to laboratory testing and information. “Our Cinch product line is a step above what is currently being offered in the market for directto-consumer laboratory testing,” said Shawn Whitcomb, PAML’s Chief Information Officer in a press release. “We are delivering the same superiority in laboratory testing that patients receive from their physician, but with much more convenience and flexibility, and often at a lower cost than a traditional physician visit.”
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Additionally, PAML recently launched another brand titled AION (meaning “life” or “longevity” in Greek) which aims to assist physicians practicing personalized medicine by delivering evidencebased testing utilizing robust diagnostic technology to detect risk factors and biomarkers associated with aging. Through clinical relevance and uniformity of testing, AION aids physicians in their efforts to monitor patients and manage treatment programs over time. AION also provides nationwide concierge phlebotomy services to healthcare providers that do not have in-house drawing personnel, as well as an online portal delivering enhanced reports. “We’ve segmented the areas of wellness we serve into traditional and clinical wellness, wellness for consumers, wellness for the ageing population and we’re now entering into corporate wellness for employees,” said Dr. Velázquez. Why Choose PAML? “In short, we’re a true partner,” said Dr. Velázquez. “Our goal is for you to w w w. p a m l . c o m
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succeed. We’re focused on quality and service in terms of providing for those that work with us.� As a value-driven organization, PAML looks to enhance the skills and abilities of its clients all while remaining community-centric.
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Mindful of its presence in the community, PAML is constantly looking to locally brand joint ventures for the benefit of its partners and the community as a whole. “Our goal is to do upwards of 90 percent of the volume generated in a
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Company Information INDUSTRY
PAML HEADQUARTERS
Healthcare FOUNDED
1957 EMPLOYEES
1000 REVENUE
$250 M PRODUCTS/ SERVICES
www.paml.com
particular region locally,” explained Dr. Velázquez. “That way we can increase the efficiency of our local partners, provide them with a revenue stream they didn’t previously have, and maintain the continuity of information for the region of delivered care.”
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PAML Address 629 N. Iron Court Tel. (509) 755-8600 www.paml.com