NEW YORK (GenomeWeb News) - Osmetech said today that it has submitted to the US Food and Drug Administration a test to identify patients who are at risk for sensitivity to the blood-thinner warfarin.
Osmetech said it conducted studies for the eSensor 2C9/VKOR test on its eSensor XT-8 tool at three evaluation sites, and that pre-clinical studies completed in November 2007 showed the test to be in agreement with results from bidirectional DNA sequencing.
In August, the FDA updated its label for warfarin to explain that an individual’s genetic makeup may influence response to a drug and may influence optimal dosing.
Osmetech’s CEO, James White, said the company is confident that it will receive clearance from the FDA for the test in the first half of this year.
The FDA in September cleared a test for warfarin sensitivity made by Nanosphere.