ParagonDx Prepares Molecular Diagnostics Expansion after Acquisition of Gentris Diagnostics
News Aug 30, 2007
ParagonDx LLC 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.
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.”
China is poised to introduce a new regulation on gene editing in humans. A draft of the country’s new civil code lists human genes and embryos in a section on personality rights to be protected. Experiments on genes in adults or embryos that endanger human health or violate ethical norms can accordingly be seen as a violation of a person’s fundamental rights.READ MORE