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Cepheid Eyes EUA from FDA for H1N1 Test

NEW YORK (GenomeWeb News) – A Cepheid official said yesterday that the firm expects to receive Emergency Use Authorization from the US Food and Drug Administration soon for the firm's molecular test for the 2009 influenza A H1N1 virus.

Cepheid CFO Andrew Miller said yesterday at the UBS Global Life Sciences Conference held here that the firm expects to file for full FDA clearance of the test after it receives the EUA. He said that the test will identify H1, H3, and novel H1N1 strains and will provide results in 45 minutes.

The flu test is one of several planned for launch for 2010, according to Miller. Among the others are more tests for methicillin-resistant Staphylococcus aureus and vancomycin-resistent enterococci, and a BCR-ABL test for monitoring patients being treated for chronic myelogenous leukemia. The firm also intends to file for FDA clearance of its HemosIL FII/FV test by the end of this year, noted Miller.

Earlier this year, Cepheid launched its Xpert MTB/RIF test in Europe as a CE IVD Mark product. The test can simultaneously identify Mycobacterium tuberculosis (MTB) and resistance to rifampicin (RIF), a common first-line drug for treatment of the disease and a reliable surrogate marker of strains that are multidrug-resistant.

Miller said yesterday that the launch of the MTB test is a "door opener" for getting labs in Europe to purchase the firm's GeneXpert system. He said that once they get the MTB test and GeneXpert system they realize that there are already 11 CE-IVD tests that Cepheid offers. According to Miller, the MTB, flu A, and its Clostridium difficile test all have the potential to drive system placements.

Miller also noted that Cepheid shipped its first GeneXpert Infinity 48 system, the newest in its line of GeneXpert systems, this week. He said that the system, which can provide nearly 2,100 test results in a 24-hour period, was purchased by a Veterans Administration hospital in Florida.

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