Cepheid Announces European Release of First On-Demand Molecular Pre-Surgical Screening Test for Simultaneous Detection of Methicillin-Sensitive and Resistant S. aureus

By Prne, Gaea News Network
Monday, March 30, 2009

SUNNYVALE, California - World’s Most Comprehensive On-Demand HAI Test Portfolio Now Available
to European Hospitals

Cepheid (Nasdaq: CPHD) today announced the release of the Xpert(R)
MRSA/SA Nasal test as a European CE IVD Mark product under the European
Directive on In Vitro Diagnostic Medical Devices. The test is designed for
the simultaneous detection of nasal carriage of both Methicillin-resistant
Staphylococcus aureus (MRSA) and Methicillin-sensitive Staphylococcus aureus
in less than one hour. Xpert MRSA/SA Nasal is Cepheid’s tenth CE IVD test for
use on the GeneXpert(R) System, the world’s leading Healthcare Associated
Infection (HAI) molecular testing platform.

“With the addition of Xpert MRSA/SA Nasal, Cepheid now offers European
clinicians the most comprehensive suite of on-demand molecular tests
currently available to aid in the overall management of HAIs,” said John
Bishop, Cepheid’s Chief Executive Officer. “This includes a broad line of
diagnostic, surveillance, and pre-surgical screening tests for MRSA, SA, C.
difficile, and vanA/vanB.”

Staphylococcus aureus is widely recognized as one of the most common
causes of HAIs worldwide. Surgical units are high-risk areas for potentially
serious consequences of post-operative complications, including surgical site
infections (SSIs). Cepheid’s on-demand Xpert MRSA/SA Nasal test provides
rapid determination of pre-operative carrier status by detecting MRSA and S.
aureus, enabling clinicians to determine the best course of treatment for
colonized patients.

“Determining pre-operative carrier status of S. aureus, including MRSA,
can be helpful in targeting patient treatment, including decolonization,
shown to reduce post operative SSIs,” said Professor Jan Kluytmans, MD,
Professor of Medical Microbiology and Infection Control, VUmc, Amsterdam.
“This is particularly important given the high economic burden of S. aureus
infection among patients admitted for elective surgery.”

Conventional lab culture techniques require at least 24 hours to identify
S. aureus. In contrast, rapid diagnostic tests can yield results at time of
the initial preadmission screening visit, so clinicians can better counsel
patients if results are positive, and can consider enhanced treatment
approaches including decolonization to reduce the risk of post-surgical
infectious complications.

Carriers of MRSA and S. aureus are at increased risk of developing
post-operative SSIs. Studies have shown up to 80 percent of hospital-acquired
S. aureus infections are caused by the patients’ own flora, and colonized
patients are up to nine times more likely to develop surgical site infections
than non-carriers. As of April 1, the UK Department of Health has provided
guidance that all NHS trusts must introduce MRSA screening for all elective
surgery admissions. They must also extend screening to cover all emergency
admissions no later than 2011.

Recent reports note that 29 million surgical procedures are performed
each year in Europe and approximately 2.6 percent of these patients develop
SSIs while recuperating in European hospitals. Once a patient has developed
an SSI, their average length-of-stay is increased by 6.5 days and it costs
three times as much to treat an infected person.

About Cepheid

Cepheid (Nasdaq: CPHD), based in Sunnyvale, Calif., is a molecular
diagnostics company that develops, manufactures, and markets fully-integrated
systems and tests for genetic analysis in the clinical, industrial and
biothreat markets. The company’s systems enable rapid, sophisticated genetic
testing for organisms and genetic-based diseases by automating otherwise
complex manual laboratory procedures. The company’s easy-to-use systems
integrate a number of complicated and time-intensive steps, including sample
preparation, DNA amplification and detection, which enable the analysis of
complex biological samples in its proprietary test cartridges. Through its
strong molecular biology capabilities, the company is focusing on those
applications where rapid molecular testing is particularly important, such as
identifying infectious disease and cancer in the clinical market; food,
agricultural, and environmental testing in the industrial market; and
identifying bio-terrorism agents in the biothreat market. See www.cepheid.com
for more information.

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; regulatory developments and changing
practices regarding testing; customer and market acceptance of the product;
the failure of products to perform 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 economic conditions . Readers should also refer to
the section entitled “Risk Factors” in Cepheid’s Annual Report on Form 10-K
for 2008, 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.

CONTACTS:
For Media Inquiries: For Cepheid Investor Inquiries:
Jared Tipton Jacquie Ross
Cepheid Corporate Communications Cepheid Investor Relations
+1-408-400-8377 +1-408-400-8329
jared.tipton@cepheid.com investor.relations@cepheid.com

Source: Cepheid

media, Jared Tipton, Cepheid Corporate Communications, +1-408-400-8377, jared.tipton at cepheid.com, or investors, Jacquie Ross, Cepheid Investor Relations, +1-408-400-8329, investor.relations at cepheid.com

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