NEW YORK (GenomeWeb News) – Cepheid said after the close of the market Thursday that the US Food and Drug Administration has cleared for marketing its Xpert HemosIL FII & FV test.
The test detects Factor II and V Leiden genetic variations associated with thrombophilia. It runs on the firm's GeneXpert system and provides results in just over 30 minutes. The test will be distributed exclusively by Instrumentation Laboratory.
The Xpert HemosIL FII & FV is Cepheid's eighth test to receive FDA clearance. IL launched the test in Europe in March 2008, and its CEO, Josep Manent, said in a statement that customer response there has been "extremely positive."