Wednesday, July 23, 2008

Warfarin Sensitivity Test Gets FDA OK

Filed under: Medicine

The FDA has given clearance to Osmetech's eSensor Warfarin Sensitivity Test, which checks for three genetic markers in a patient's DNA that are linked to greater sensitivity to the anti-coagulant.

Warfarin is the most widely prescribed oral anticoagulant in North America and Europe with an estimated 2 million new patients in the US each year. Warfarin is the second-most-likely drug, after Digoxin, to cause adverse events requiring hospitalization. A recent economic study (Brookings Institute, November 2006) concluded that widespread use of warfarin sensitivity testing in the U.S. could avoid 85,000 serious-bleeding events and 17,000 strokes a year, saving healthcare costs of approximately $1.1 billion annually and improving patient care.

Our eSensor Warfarin Sensitivity Test detects the three genetic markers that are known to play a critical role in metabolism of, and sensitivity to, warfarin. Through detection of these genetic markers, doctors are better able to accurately and efficiently determine the appropriate warfarin dosage level. Individuals respond to warfarin differently, and if its administration is not managed carefully, life threatening side effects may occur. Last year, the FDA cleared updated labeling for Coumadin® (generic name warfarin) recognizing the role of CYP2C9 and VCORC1 genes in warfarin metabolism.

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