Press Release

 

Osmetech plc ('Osmetech' or the 'Company')

Commencement of clinical trials for warfarin

12 November 2007

 

 

Osmetech plc (OMH.L), the fast developing international molecular diagnostics business announces that it has commenced clinical trials for its genetic eSensor® 2C9/VKOR test 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 will be performed at three trial sites with the results supporting the Company’s submission for 510(k) clearance to the US Food and Drug Administration (FDA) for the 2C9/VKOR assay together with its next generation eSensor® XT-8 instrument.

 

Highly successful pre-clinical studies have recently been completed and the results were presented at the AMP (Association for Molecular Pathology) major US trade exhibition held on 7-10 November. 352 samples were tested using Osmetech’s eSensor® 2C9/VKOR method and found to be in 100% agreement with results from bi-directional DNA Sequencing, with zero no-calls.

 

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 (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 outstanding results of the pre-clinical studies and are confident of successful clinical trials and achieving FDA clearance to launch our warfarin test in the first half of 2008.


“We believe that the Osmetech eSensor® 2C9/VKOR warfarin test has many key attributes which should lead to commercial success in this growing and significant market. Notably, our easy to perform test includes the important warfarin biomarker exclusively licensed from Marshfield Clinic in Wisconsin, US.”

 

Osmetech plc                                                       +44 (0)207 849 6027

James White, Chief Executive Officer

David Sandilands, Chief Financial Officer

 

Madano Partnership                                             +44 (0) 207 593 4000

Matthew Moth, Graham Moonie

 

Hoare Govett Limited                                            +44 (0) 207 678 8000

Andrew Foster (Corporate Broking)
Justin Jones (Corporate Finance)



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®, 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.