"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.

Cepheid expects Xpert Flu A Panel to become available in Europe as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices the week of December 28, 2009.