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 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.
About Cepheid
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.
References:
-
http://www.euro.who.int/en/what-we-do/health-topics/communicable-diseases/influenza/facts-and-figures/seasonal-influenza
- http://www.cdc.gov/h1n1flu/
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CONTACTS:
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For Media
Inquiries:
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For Cepheid Investor
Inquiries:
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Jared Tipton
Cepheid Corporate
Communications
408-400-8377
communications@cepheid.com
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Jacquie Ross
Cepheid Investor
Relations
408-400-8329
investor.relations@cepheid.com
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SOURCE Cepheid