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EU Clears Cepheid Thrombophilia Tests

NEW YORK (GenomeWeb News) – Cepheid today said that European Union regulatory authorities have cleared the firm’s Xpert HemosIL FII & FV assay for marketing.
 
The assay detects Factor II and Factor V Leiden genetic variations associated with thrombophilia. The test was developed for use on Cepheid’s GeneXpert multiplex molecular diagnostics system.
 
Cepheid’s exclusive worldwide distributor for hemostasis tests, Instrumentation Laboratory, will begin selling the assay on March 4. It is the first test to be commercialized under a partnership between the firms that was signed in April 2007, and will complement IL’s current line of hemostasis assays including antithrombin, protein C, protein S, homocysteine, and lupus anticoagulants.
 
"Given the complexity of traditional molecular diagnostics, clinical laboratories currently may wait up to a week for FII and FV genotyping,” Cepheid CEO John Bishop said in a statement. “The Xpert HemosIL FII & FV assay will allow laboratories to perform the test as needed — and integrate the results with other tests — providing physicians a comprehensive thrombophilia profile of their patients.”
 
The new assays also target a new market for Cepheid, which has concentrated its commercial efforts so far on molecular diagnostic tests for hospital-acquired infections. While the HAI market remains the primary focus of the firm, it also is developing tests for tuberculosis and human papillomavirus.

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