FDA News

FDA Clears Osmetech's Warfarin Sensitivity Test and New eSensor XT-8 Platform

(July 22, 20080-- Osmetech has announced that it 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 Company also announces that the FDA clearance includes its second generation eSensor XT-8 molecular diagnostics platform.

James White, Chief Executive, 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. 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.

Our second generation platform, the eSensor XT-8, is designed to support a broad menu of tests and provide accurate results while minimizing technician involvement. We believe that 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.

Please visit  www.osmetech.com for more information.

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