Cepheid announced the release of Xpert Flu as a European CE IVD mark product under the European Directive on In Vitro Diagnostic Medical Devices. The test, which runs on Cepheid's GeneXpert System, simultaneously detects and differentiates flu A, flu B, and 2009 H1N1 influenza virus in about one hour.

“While seasonal influenza strains appear to be of usual concern this season, the European resurgence of 2009 H1N1 highlights the critical need for accurate, rapid, and easy-to-use diagnostic solutions for all of the major influenza strains in circulation,” said John Bishop, Cepheid's chief executive officer. “Although molecular testing is now recognized as the new gold standard for detection of influenza, testing is generally limited to highly complex laboratories and results may not typically be available around the clock. Xpert Flu provides an easy-to-use, on-demand molecular influenza test that can assist clinicians in making real-time medical decisions 24 hours a day.”

2009 H1N1 is a novel influenza virus first detected in the United States in April 2009. While no longer at pandemic levels, a December 2010 report from the European Centre for Disease Prevention and Control indicates that the start of the 2010-11 European influenza season is being dominated by 2009 H1N1 virus. The report goes on to recommend: “Countries should be prepared for increased demand for healthcare assistance and promote early sample collection and testing for patients with influenza-like-illness.”

Xpert Flu is available now as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. Xpert Flu is expected to become available in the United States in early 2011.

Based in Sunnyvale, California, Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests.