Osmetech plc (LSE:OMH) won Food & Drug Administration 510(k) clearance for its eSensor diagnostic for thrombophilia, a hereditary condition involving a propensity to develop blood clots.
The British company, which has operations in Rockland, Mass., said the test is a molecular diagnostic designed to detect four genetic markers associated with thrombosis. President and CEO Faiz Kayyem said the company believes it’s the first and only test to win FDA clearance for the four markers associated with thrombophilia, according to a press release.
It’s the third Osmetech test to win clearance from the federal watchdog agency. The FDA cleared the company’s tests for a molecular-level test to identify patients at risk of complications from Warfarin, a popular blood-thinning drug, as well as a test to detect people who are carriers of cystic fibrosis. All three tests are designed for Osmetech’s XT-8 electronic DNA detection platform.
Late last year Osmetech sold $16.3 million worth of new stock, slating part of the proceeds for the build-out of an U.S. sales force after scrapping a U.S. distribution deal with Thermo Fisher Scientific Inc. (NYSE:TMO).