Cepheid Receives FDA Clearance for Xpert Flu, Delivering Simultaneous Detection and Differentiation of Flu A, Flu B, and 2009 H1N1 Strain
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 XpertÂ® Flu. The diagnostic test, which runs on Cepheid’s GeneXpertÂ® 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.(1)
“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.(2)
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. For more information on Xpert Flu and Cepheid’s complete menu of accurate, rapid & easy-to-use molecular tests, please visit: http://www.cepheid.com/flu.
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) 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. By automating highly complex and time-consuming manual procedures, the company’s solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.
This press release contains forward-looking statements that are not purely historical regarding Cepheid’s or its management’s intentions, beliefs, expectations and strategies for the future, including those relating to product performance and future market opportunities. Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from the company’s current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: unforeseen manufacturing problems; uncertainties in the regulatory review process for new products; regulatory developments and practices regarding testing levels; customer and market acceptance of the product; the failure of products to perform as fast or as accurately as expected, whether due to manufacturing errors, defects or otherwise; the impact of competitive products and pricing; potentially lengthy sales cycles in some markets; reimbursement rates for the products; and underlying market conditions worldwide. Readers should also refer to the section entitled “Risk Factors” in Cepheid’s Annual Report on Form 10-K for 2010 and in its most recent quarterly report on Form 10-Q, each filed with the Securities and Exchange Commission.
All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to Cepheid, and Cepheid assumes no obligation to update any such forward-looking statement or reasons why results might differ.
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