Cepheid has unveiled Xpert Flu test as a European CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices.
The Xpert Flu 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.
Cepheid CEO John Bishop said that 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.
"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," Bishop said.
"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."
Based in Sunnyvale, California, Cepheid is a molecular diagnostics company that improves healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests.