Skip to main content

Osmetech Plc: Warfarin Test Submitted For FDA Approval

LONDON--(BUSINESS WIRE)--Jan 7, 2008 - Osmetech plc ('Osmetech' or the 'Company') (LSE:OMH), the fast developing international molecular diagnostics business announces that it has submitted its eSensor(R) 2C9/VKOR test to the US Food and Drug Administration (FDA) for 510(k) pre-marketing clearance. The test is to be used as an aid in the identification of patients at risk for increased sensitivity for the widely used blood-thinning drug, warfarin.

Clinical studies were performed at three evaluation sites in the US using the Company's next generation eSensor(R) XT-8 instrument. These followed the highly successful pre-clinical studies completed in November 2007 where 345 samples were tested using Osmetech's eSensor(R) 2C9/VKOR method and found to be in 100% agreement with results from bi-directional DNA Sequencing.

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.

In August 2007, the FDA approved updated labelling for Coumadin(R) (generic name warfarin) requiring manufacturers to explain that an individual's genetic makeup may influence how they respond to the drug and influence optimal dosing.

James White, Chief Executive, Osmetech plc, said:

"We are delighted with the performance of our warfarin test and are confident of achieving FDA clearance to launch our warfarin test in the first half of 2008.

"We believe that the Osmetech eSensor(R) 2C9/VKOR warfarin test has many key attributes which should lead to commercial success in this growing and significant market."

About Osmetech plc

(www.osmetech.com)

Osmetech plc is an AIM-listed public company on the London Stock Exchange. The company is a well funded, fast developing, international diagnostics business with operations in Boston and Pasadena in the US, serving the high growth molecular diagnostic market targeting hospitals and reference laboratories. Osmetech has launched eSensor(R), an FDA cleared electrochemistry-based array system, for Cystic fibrosis carrier detection and will launch a number of genetic and pharmacogenomic assays utilizing its proprietary technology in the near future.

Contact

Osmetech plc
James White, +1 781 534 2498
Chief Executive Officer

Posted: January 2008

More news resources

Subscribe to our newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.