OMH Osmetech

Osmetech plc (LSE:OMH), the fast growing international molecular diagnostics company announces that it has received US Food & Drug Administration (�FDA�) 510(k) clearance for its eSensor� Cystic Fibrosis Genotyping Test for use on the eSensor� XT-8 System. This multiplex test is used for cystic fibrosis carrier screening for adults of reproductive age, as an aid in newborn screening for cystic fibrosis, and as a confirmatory diagnostic test for cystic fibrosis in newborns and children.

This is the second FDA 510(k) cleared multiplex test the company has for use on the eSensor XT-8 System and follows clearance of a Warfarin Sensitivity Test. The Warfarin Sensitivity Test is used as an aid in the identification of patients at risk for increased sensitivity to the widely used blood-thinning drug warfarin.

Osmetech expects further commercial progress in 2009 by expanding the eSensor XT-8 test menu to include an extended Warfarin Sensitivity Test panel that includes CYP 4F2, a CYP 2C9 Genotyping panel, a venous thrombosis panel of Factor V, Factor II and MTHFR and a Respiratory Virus Pathogen panel.

James White, Chief Executive, Osmetech plc, commented: "This FDA clearance marks the start of the broadening of the menu of FDA cleared tests available to our growing base of eSensor XT-8 System customers. Our proprietary, multiplexed DNA eSensor technology allows for the rapid development of new tests which we plan to commercialise globally consistent with market demands.�

�We have been delighted with the excellent operational performance of our eSensor XT-8 System in the market and we will now transition our first generation eSensor 4800 cystic fibrosis carrier detection customers over to the eSensor XT-8 System, enabling them to benefit from its many advantages including greater ease of use and widening test menu.�

Osmetech (LSE:OMH)
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Osmetech (LSE:OMH)
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From Jan 2024 to Jan 2025