Osmetech receives FDA clearance for warfarin sensitivity test

30 July 2008

Molecular diagnostics company Osmetech plc (OMH.L) has received 510(k) clearance from the US Food & Drug Administration (FDA) 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 FDA clearance also includes its second generation eSensor XT-8 molecular diagnostics platform.

James White, Chief Executive of Osmetech plc said, "The FDA clearance is an important milestone for Osmetech. As we gear up the launch of our warfarin sensitivity test in the US this clearance provides further validation of our strategy of targeting the exciting opportunities in the rapidly developing molecular diagnostics market

“With key technological and regulatory challenges having now been met, we are confident of further commercial success with the launch of our new eSensor XT-8 platform supported by a growing menu of tests planned to include pharmacogenetics, genetic diseases and infectious diseases.”

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. It is the second-most-likely drug, after Digoxin, to cause adverse events requiring hospitalisation. A study by the Brookings Institute (November 2006) concluded that widespread use of warfarin sensitivity testing in the US 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.

Osmetech'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 labelling for Coumadin (generic name warfarin) recognizing the role of CYP2C9 and VCORC1 genes in warfarin metabolism.

Your browser does not support inline frames or is currently configured not to display inline frames.	Your browser does not support inline frames or is currently configured not to display inline frames. Osmetech receives FDA clearance for warfarin sensitivity test 30 July 2008 Molecular diagnostics company Osmetech plc (OMH.L) has received 510(k) clearance from the US Food & Drug Administration (FDA) 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 FDA clearance also includes its second generation eSensor XT-8 molecular diagnostics platform. James White, Chief Executive of Osmetech plc said, "The FDA clearance is an important milestone for Osmetech. As we gear up the launch of our warfarin sensitivity test in the US this clearance provides further validation of our strategy of targeting the exciting opportunities in the rapidly developing molecular diagnostics market “With key technological and regulatory challenges having now been met, we are confident of further commercial success with the launch of our new eSensor XT-8 platform supported by a growing menu of tests planned to include pharmacogenetics, genetic diseases and infectious diseases.” 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. It is the second-most-likely drug, after Digoxin, to cause adverse events requiring hospitalisation. A study by the Brookings Institute (November 2006) concluded that widespread use of warfarin sensitivity testing in the US 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. Osmetech'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 labelling for Coumadin (generic name warfarin) recognizing the role of CYP2C9 and VCORC1 genes in warfarin metabolism. Your browser does not support inline frames or is currently configured not to display inline frames. To top	Your browser does not support inline frames or is currently configured not to display inline frames.