News: Osmetech Plc: Warfarin Test Submitted For FDA Approval. …
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.
