Healthcare Industry News:  coumadin 

Diagnostics FDA

 News Release - August 17, 2007

Osmetech responds to U.S. Food and Drug Administration ('FDA') update labelling for warfarin

LONDON--(HSMN NewsFeed)--Osmetech plc (LSE:OMH ), the fast developing international molecular diagnostics business, notes yesterday's announcement by the FDA regarding the approval of updating labelling for the widely used blood-thinning drug, coumadin, to explain that an individual's genetic makeup may influence how they respond to the drug.

The FDA also stated that manufacturers of warfarin, the generic version of coumadin, are to add similar information to their products' labelling to facilitate optimal dosing.

Osmetech, through its molecular diagnostic platform, is developing assays to better understand individual responses and predications towards certain drugs including warfarin. It recently took a licence with University of Washington to Vitamin K Epoxide Reductase (VKOR) gene polymorphisms, a key diagnostic marker for the management of warfarin dosage.

In the US alone, over 30 million warfarin prescriptions were made last year, including an estimated 2 million new patients. Warfarin is the second-most-likely drug, after insulin, to send Americans to the emergency room, resulting in an estimated 43,000 ER visits a year in the U.S. A recent economic study concluded that widespread use of warfarin testing in the U.S. could avoid 85,000 serious-bleeding events and 17,000 strokes a year, and save about $1.1 billion annually

Later this year Osmetech will be submitting its warfarin assay along with its next generation eSensor XT-8 molecular diagnostic platform as part of its own development towards personalized medicine and looks forward to launching its warfarin test in the first half of 2008.

James White, Chief Executive, Osmetech plc, said:

"Rapid progress is being made towards the development of personalised medicine and this announcement by the FDA to approve labelling change for warfarin is another step in that direction."

"Predicting a patient's response to drugs based upon that person's genetic makeup presents significant opportunities to drive down costs for health providers and at the same time substantially improve the quality of healthcare and patient recovery.

"Osmetech has been moving aggressively to place itself at the forefront of the molecular diagnostics industry through warfarin and its FDA approved products. This development by the FDA confirms Osmetech is ideally placed to benefit in this rapidly growing sector."

For a complete copy of the FDA's announcement: www.fda.gov/bbs/topics/NEWS/2007/NEW01684.html


Source: Osmetech

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