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Cepheid (CPHD) Receives FDA Clearance for Xpert Flu, Delivering Simultaneous Detection and Differentiation
of Flu A, Flu B, and 2009 H1N1 Strain
4/26/2011 6:35:02 AM
SUNNYVALE, Calif., April 26, 2011 /PRNewswire/ Cepheid (NASDAQ:CPHD News) 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 easytouse 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 35 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 easytouse
molecular Flu test can assist clinicians in making realtime 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 & easytouse molecular
tests, please visit: http://www.cepheid.com/flu.
About Cepheid
Based in Sunnyvale, Calif., Cepheid (Nasdaq:CPHD News) is a leading molecular diagnostics company that is
dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easytouse molecular
systems and tests. By automating highly complex and timeconsuming 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 forwardlooking 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 10K for 2010 and in its most recent quarterly report on Form 10Q,
each filed with the Securities and Exchange Commission.
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All forwardlooking 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 forwardlooking statement or reasons why results might differ.
References:
1. http://www.euro.who.int/en/whatwedo/healthtopics/communicablediseases/influenza/factsandfigures/seasonal
influenza 2. http://www.cdc.gov/h1n1flu/
CONTACTS:
For Media Inquiries: For Cepheid Investor Inquiries: Jared Tipton Cepheid Corporate Communications 4084008377
communications@cepheid.com
Jacquie Ross Cepheid Investor Relations 4084008329 investor.relations@cepheid.com
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