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Osmetech plc ('Osmetech' or the 'Company')
Extended warfarin sensitivity test submitted for FDA approval
6 January 2009
Osmetech plc (OMH.L), the international molecular diagnostics company announces that it has submitted its eSensor® Warfarin Sensitivity Extended Panel Test to the US Food and Drug Administration (FDA) for 510(k) pre-marketing clearance.
Osmetech obtained clearance from the US Food and Drug Administration (FDA) in July 2008 for its eSensor® Warfarin Sensitivity Test to be used as an aid in the identification of patients at risk for increased sensitivity to the widely used blood-thinning drug, warfarin. The new extended warfarin test incorporates a number of additional markers, including the CYP450 4F2 biomarker exclusively-licensed from Marshfield Clinic.
James White, Chief Executive, Osmetech plc, said:
"We are excited by the prospects of being able to provide what we believe will be the most comprehensive FDA-cleared test for warfarin sensitivity available in the marketplace, which will include the important and unique biomarker, 4F2.”
Osmetech plc +44 (0)207 849 6027
James White, Chief Executive Officer
David Sandilands, Chief Financial Officer
Madano Partnership +44 (0) 207 593 4000
Graham Moonie, Dominic Barretto
Canacccord Adams Limited +44 (0) 207 050 6500
Robert Finlay, Henry Fitzgerald-O’Connor
About Osmetech plc
(www.osmetech.com)
Osmetech plc is an AIM-listed public company on 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 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.
Osmetech’s second generation platform, the eSensor XT-8 received FDA 510(k) clearance in July 2008 together with our eSensor Warfarin Sensitivity Test. These products are now being marketed in the U.S. together with our 2C9 Genotyping Test for the drug metabolism gene, CYP450 2C9, which is available for research use purposes only.
The eSensor XT-8 System is designed to support a broad menu of tests and Osmetech has scheduled for commercial launch a number of further tests including: extended warfarin panel with our proprietary 4F2 marker, Cystic Fibrosis, venous thrombosis (Factor II, Factor V Leiden and MTHFR) and the RESPLEX II respiratory pathogen assay recently in-licensed from Qiagen. The System provides accurate results while minimizing technician involvement and we believe that its features compare favorably to those of other molecular detection systems. Its ease of use, readily interpretable results, speed and low maintenance are particularly suited to the needs of the decentralizing market.