FDA Clears Osmetech's Cystic Fibrosis Genotyping Test

Main Category: Cystic Fibrosis
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 10 Jul 2009 - 6:00 PDT

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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."

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Osmetech plc