Healthcare Industry News: coumadin
News Release - August 29, 2007
ParagonDx Prepares Molecular Diagnostics Expansion After Acquisition of Gentris Diagnostics, Inc.New Company Will Focus on Genetic Testing Market; Series of New Products Planned
MORRISVILLE, N.C.--(HSMN NewsFeed)--ParagonDx LLC, a leader in genetic and molecular testing diagnostics, has acquired the assets of Gentris Diagnostics, Inc, a subsidiary of Gentris Corporation. As a stand-alone company, ParagonDx will focus on developing molecular diagnostic products for laboratories. These products are intended to enhance medical care by providing early diagnostic information rapidly. This should benefit patients and save money for the healthcare system.
Michael P. Murphy, former President and CEO of Gentris Corporation, will serve as the President and CEO of ParagonDx.
Among the key assets ParagonDx purchased from Gentris Diagnostics were the first six FDA-cleared human genomic reference controls and forty-six other reference control products currently being sold to reference laboratories and diagnostic product developers. Reference controls help assure the quality of genetic tests, while pharmacogenomic tests explain how an individual's genetic makeup affects their response to drugs.
Another key asset is a new in vitro diagnostic test to determine a safe starting dose of warfarin also known as coumadin, a blood thinner that prevents and treats blood clots.
The formation of ParagonDx comes in the wake of the announcement on August 16, 2007, by the U.S. Food and Drug Administration (FDA) to update warfarin's label to include genetic testing information. At a recent pharmacogenetics conference, Dr. Lawrence Lesko, director of the FDA's Office of Clinical Pharmacology & Biopharmaceutics, said the agency wants to "improve the one-size-fits-all dosing in order to optimize benefit/risk" with genetic information.
In the future, the company plans a series of products for molecular testing. ParagonDx will improve genetic tests, currently made as "home-brew" or Laboratory Developed Tests (LDTs), and take them through the FDA clearance process. With FDA clearance, these tests can be used in the clinical setting to improve diagnoses and patient health.
"Our diagnostic products represent a significant advancement in patient safety," said ParagonDx President and CEO Michael Murphy. "Warfarin dosing, for example, is clearly related to an individual's genetic make-up. Getting the right dose to patients earlier decreases the chance that they will have excessive bleeding or another heart attack or stroke."
Joe Sorge, founder and former CEO of Stratagene, a company that sold research reagents and equipment to the life sciences industry before it was acquired by Agilent in June, has assumed a controlling interest in ParagonDx. Gentris Corporation will retain a minority stake in the new company.
"Molecular diagnostics is an emerging market," Sorge said. "Small, nimble companies such as ParagonDx will be able to adapt to rapidly changing conditions and bring tests to market that will actually help patients."
ParagonDx, located in Morrisville, NC, is a leading provider of applied molecular diagnostic products. Initially a pioneer in the field of pharmacogenomics, ParagonDx has broadened its expertise into molecular diagnostic products. ParagonDx develops and markets reference controls for laboratory quality control and diagnostic kits that bring the promise of personalized medicine to physicians and patients. ParagonDx was the first company to bring FDA-cleared human genomic reference controls to the market. These products are intended to enhance patient safety, improve patients' response to therapy and help realize the promise of personalized medicine. For additional information, please visit www.ParagonDx.com.
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