FDA approval covers influenza A, influenza B, and the 2009 H1N1 virus.
Cepheid expects to have its Xpert® Flu diagnostic available for shipping in two weeks, after receiving FDA clearance to market the product.The test, which runs on Cepheid’s GeneXpert® System, detects and differentiates influenza A, influenza B, and the 2009 H1N1 influenza virus simultaneously in about one hour.
“While molecular testing is widely recognized as the new gold standard for detection of influenza, it has generally been limited to highly complex laboratories,” Cepheid CEO John L. Bishop states. ‘Xpert Flu empowers institutions with moderate complexity laboratories to have a molecular influenza test available to their physicians 24 hours a day.”
Xpert Flu requires less than two minutes hands-on time and uses a single-use cartridge design that enables on-demand STAT testing, according to Cepheid. It is also available as a CE mark in vitro diagnostic product.