FDA EUA for First 2009 H1N1 Assay for CLIA 'Moderate Complexity' Labs

Cepheid has been granted Emergency Use Authorization (EUA) from the FDA for its Xpert® Flu A Panel test. The test, which runs on Cepheid's GeneXpert(R) System, identifies the 2009 H1N1 influenza virus in less than one hour. The FDA has authorized Cepheid's Xpert Flu A Panel to be used in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform 'moderate complexity' (not waived) testing, enabling the test to be performed in hospital near-patient settings.

'Accuracy combined with ease-of-use and the broad testing applicability of the GeneXpert(R) System offers a helpful unique diagnostic solution in helping to address this healthcare issue,' said John Bishop, Cepheid's Chief Executive Officer. 'Although PCR testing is now recognized as the new gold standard for detection of influenza virus infection, test availability for 2009 H1N1 has so far been limited to high-complexity laboratories and results are not typically available around the clock. Xpert Flu A Panel combines the convenience and ease-of-use of rapid testing with the performance of PCR, in a test format that maximizes medical value by providing results when they are most needed.'

'So far, 2009 H1N1 appears to be the predominant influenza strain this season,' said Dr. Preveen Ramamoorthy, director of molecular diagnostics at National Jewish Health in Denver CO. 'An easy-to-use, rapid PCR-based 2009 H1N1 test can assist clinicians in making real-time medical decisions that help hospitals significantly improve their patient management.'

Cepheid will continue development of an expanded influenza panel product that it expects to test for Influenza A with strain identification for H1 seasonal and H3 seasonal influenza A subtypes, the 2009 H1N1 subtype, and Influenza B. For that product, Cepheid expects to submit a separate 510(k) in 2010.