August 1, 2008 - Osmetech said this week at the American Association for Clinical Chemistry (AACC) 2008 Conference and Exhibition in Washington, D.C., that following receipt of its 510(k) clearance last week from the FDA the company has commenced shipments of its second generation eSensor XT-8 molecular diagnostics platform and Warfarin Sensitivity Test.
Warfarin is the most widely prescribed oral anticoagulant in North America and Europe with an estimated 2 million new patients in the U.S. each year. Warfarin is the second-most-likely drug, after insulin, to cause adverse events requiring emergency room visits. 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.
The company’s 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.
For more information: www.osmetech.com