FDA grants Cepheid marketing clearance for Xpert Flu diagnostic test

Cepheid (NASDAQ: CPHD) today announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market Xpert® Flu. The diagnostic test, which runs on Cepheid's GeneXpert® System, simultaneously detects and differentiates Influenza A, Influenza B, and the 2009 H1N1 influenza virus in about one hour.

"With Xpert Flu, Cepheid delivers another fast, accurate, and easy-to-use diagnostic test that detects the major influenza strains in circulation," said John Bishop, Cepheid's Chief Executive Officer. "While molecular testing is widely recognized as the new gold standard for detection of Influenza, it has generally been limited to highly complex laboratories. Xpert Flu empowers institutions with moderate complexity laboratories to have a molecular Influenza test available to their physicians 24 hours a day."

Influenza A and Influenza B, typically referred to as seasonal flu, are categorized as highly contagious, acute, viral infections of the respiratory tract. These communicable diseases are easily transmitted through coughing and sneezing and typically occur during the winter months. The Centers for Disease Control and Prevention (CDC) estimates that as much as 20 percent of the United States population get at least one strain of influenza annually. Worldwide, it is estimated to affect 3-5 million people annually with 250,000 to 500,000 deaths attributed to the disease each year.

"While seasonal Flu strains appear to have been most common this season, the European resurgence of 2009 H1N1 highlighted the need for fast, accurate, and differentiating diagnostics," said Dr. Preveen Ramamoorthy, Director of Molecular Diagnostics, Advanced Diagnostic Laboratories at National Jewish Health in Denver CO. "An easy-to-use molecular Flu test can assist clinicians in making real-time medical decisions that can significantly improve patient management."

First detected in the United States in April 2009, the H1N1 influenza virus caused the first influenza pandemic by a new flu virus in more than 40 years. While the H1N1 influenza virus is no longer at pandemic levels, the CDC anticipates the virus will continue to spread for years to come along with the regular seasonal influenza virus.

Xpert Flu is Cepheid's 11th Xpert test to receive FDA clearance, and will be available for shipment in two weeks. Xpert Flu is also available as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices.