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Canadian Authorities Clear Cepheid's Thrombophilia Test

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.

Instrumentation Laboratory will market distribute the test in Canada. The firms inked a development and distribution deal two years ago covering hemostasis diagnostics, and under that pact IL gained exclusive, worldwide distribution rights for the Xpert HemosIL FII & FV test.

"Given the complexity of traditional molecular diagnostics, clinical laboratories currently may wait up to a week for FII and FV genotyping," John Bishop, CEO of Cepheid, said in a statement. "The Xpert HemosIL FII & FV test will allow Canadian laboratories to perform the test on-demand — and integrate the results with other tests — providing physicians a more comprehensive thrombophilia profile of their patients."

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