Molecular Diagnostic Products To Be Developed and Improved

Molecular diagnostic products intended to enhance medical care by providing rapid early diagnostic information will be developed for laboratories.

Genetic tests, currently made as Laboratory Developed Tests (LDTs), will be improved and taken through the U.S. Food and Drug Administration (FDA; Rockville, MD, USA) clearance process. With FDA clearance, these tests can be used in the clinical setting to improve diagnoses and patient health.

ParagonDx LLC (Morrisville, NC, USA) is a genetic and molecular testing diagnostic company that will focus on molecular diagnostic products. The company has acquired the assets of Gentris Diagnostics, Inc. (Morrisville, NC, USA) a subsidiary of Gentris Corporation.

Among the key assets ParagonDx purchased from Gentris Diagnostics were the first six FDA-cleared human genomic reference controls and 46 other reference control products currently being sold to diagnostic product developers and reference laboratories. Another key asset is a new IVD 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 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 that the agency wants to "improve the one-size-fits-all dosing in order to optimize benefit/risk” with genetic information.

"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.”


Related Links:
ParagonDx
Gentris Diagnostics