Osmetech plc Receives 510(k) Clearance for the eSensor® Thrombophilia Risk Test

Osmetech, plc (LSE:OMH) today announced that the US Food and Drug Administration (FDA) has cleared the eSensor® Thrombophilia Risk Test (TRT), a multiplexed molecular diagnostic test for four genetic markers associated with thrombosis. The panel includes Factor V Leiden, Factor II Prothrombin, MTHFR 677 and MTHFR 1298 in a single test panel.

Thrombophilia disorders affect roughly 1 in 1,000 individuals, and genetic testing has become an accepted method of assessing an individual’s inherited risk for thrombosis and other related cardiovascular events.

“The FDA clearance of our Thrombophilia Risk Test marks a significant milestone in the development of our test menu and further demonstrates the value of our proprietary eSensor® electronic DNA detection technology,” said Faiz Kayyem, President and CEO of Osmetech, plc. “We believe that Osmetech is the first company to have achieved FDA clearance for all four thrombophilia related genetic markers.”

The eSensor® Thrombophilia Risk Test is for use on the Company’s XT-8 system, a versatile DNA detection platform for hospital and reference laboratories. TRT can be configured to report out single genetic mutation results or various combinations including a Factor V/Factor II only result and the full thrombophilia panel of all four genetic mutations. The eSensor® Thrombophilia Risk Test is the third product cleared by the FDA for use on the XT-8 system and complements existing FDA cleared products for Cystic Fibrosis and Warfarin Sensitivity.