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Cepheid Receives FDA Clearance for Xpert Flu, Delivering Simultaneous Detection and Differentiation of Flu A, Flu B, and 2009 H1N1 Strain
Date:4/26/2011

SUNNYVALE, Calif., April 26, 2011 /PRNewswire/ -- 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.

(Photo:  http://photos.prnewswire.com/prnh/20110426/LA89263)

"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.(1)

"While seasonal Flu strains appear to have been most common this season, the European resurgence of 2009 H1N1 high
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