FDA Clears Osmetech’s New Warfarin Sensitivity Test
July 22, 2008 - Osmetech today said it received FDA 510(k) clearance for its eSensor Warfarin Sensitivity Test to be used as an aid in the identification of patients at risk for increased sensitivity to the widely used blood-thinning drug, warfarin.
The company also said the FDA clearance includes its second-generation eSensor XT-8 molecular diagnostics platform.
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 Digoxin, to cause adverse events requiring hospitalization. A recent economic study (Brookings Institute, Nov. 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 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.
The company said its second-generation platform, the eSensor XT-8, is designed to support a broad menu of tests and provide accurate results while minimizing technician involvement. The company believes the features of our eSensor XT-8 System compare favorably to those of other molecular detection systems and that its ease of use, readily interpretable results, speed and low maintenance are particularly suited to the needs of the decentralizing market.
For more information: www.osmetech.com