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Osmetech plc ('Osmetech' or the 'Company')
Osmetech announces first shipments of new eSensor® XT-8 platform and Warfarin Sensitivity Test
30 July 2008
Speaking at the American Association for Clinical Chemistry (AACC) 2008 Conference and Exhibition in Washington, DC, James White, Chief Executive, Osmetech plc, will confirm later today that following receipt of its 510(k) clearance last week from the US Food & Drug Administration (‘FDA’), the Company has now commenced shipments of its second generation eSensor® XT-8 molecular diagnostics platform and Warfarin Sensitivity Test.
Mr White said: "We are delighted with the initial response from customers following the FDA clearance of the product and have a number of shipments planned to both existing customers, who are currently running Cystic Fibrosis Carrier Detection tests using our first generation platform, and new customers.
“This additional product offering leverages our commercial infrastructure which has benefited greatly from the valuable experience and momentum gained through servicing our Cystic Fibrosis test customers. As is customary in the molecular diagnostics market, the new products will initially be evaluated by customers and we are confident of achieving a high conversion rate of customers from evaluation to contract, mirroring our experience with our Cystic Fibrosis product.
“We will be broadening our test menu for the eSensor XT-8 platform and have further FDA submissions for specific tests planned for later this year and in 2009.”
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, Mark Way
Canacccord Adams Limited +44 (0) 207 050 6500
Robert Finlay
About Osmetech plc
(www.osmetech.com)
Osmetech plc is a public company listed on the AIM market of the London Stock Exchange. The company is a 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 rights to a strong portfolio of over 200 issued and pending patents and has launched its first generation eSensor 4800 platform, an electrochemistry-based array system, together with an FDA cleared in vitro diagnostic test for Cystic Fibrosis carrier detection. In July 2008, Osmetech received FDA clearance for its second generation eSensor XT-8 molecular diagnostics platform and Warfarin Sensitivity Test.
Warfarin sensitivity test
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 insulin, to cause adverse events requiring emergency room visits. 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.
eSensor XT-8
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.