SUNNYVALE, Calif., Dec. 27, 2010 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced the release of Xpert® Flu as a European CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. The 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.
"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," said John Bishop, Cepheid's Chief Executive Officer. "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. 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."
2009 H1N1 is a novel influenza virus first detected in the United States in April 2009. While no longer at pandemic levels(1), a December 2010 report from the European Centre for Disease Prevention and Control indicates that the start of the 2010-11 European influenza season is being dominated by 2009 H1N1 virus. The report goes on to recommend: "Countries should be prepared for increased demand for healthcare assistance and promote early sample collection and testing for patients with influenza-like-illness."(2)
Xpert Flu is available now as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. Visit www.cepheidinternational.com for Cepheid's complete CE IVD menu of Xpert tests. Xpert Flu is expected to become available in the United States in early 2011.
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 the timing of new product releases, regulatory developments and approvals, product availability in specified markets, and product performance. 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: product development and manufacturing problems; uncertainties in the regulatory review process for new products; regulatory developments and practices regarding testing; customer and market acceptance of the product; the failure of the product to perform as expected, whether due to manufacturing errors, design defects or otherwise; the impact of competitive products and pricing; potentially lengthy sales cycles in some markets; reimbursement rates for the product; 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 2009 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.