FDA clears Osmetech's 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.

“We believe that Osmetech is the first company to have achieved FDA clearance for all four thrombophilia related genetic markers.”

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.


Osmetech, plc


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Scientists identify over 5,000 genetic variants that enable certain cancers to thrive