NEW YORK (GenomeWeb News) – Health Canada has issued a medical device license for Cepheid's Xpert HemosIL FII & FV test, the molecular diagnostics maker said today.

The new assay detects Factor II and Factor V Leiden genetic variations that are associated with thrombophilia, an increase risk of blood clots. The test runs on the firm's GeneXpert platform and provides results in just over 30 minutes, said Cepheid.

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The US Food and Drug Administration has new guidelines that enable some gene and cell therapies to undergo expedited review, according to the New York Times.

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