SUNNYVALE, Calif., June 8 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq:
CPHD) today announced it has received clearance from the U.S. Food
& Drug Administration (FDA) to market Xpert® SA Nasal
Complete, the first and only molecular test designed for the
simultaneous detection and differentiation of both
Staphylococcus aureus (SA) and Methicillin-resistant
Staphylococcus aureus (MRSA) colonization in less than one
hour. The test runs on Cepheid's GeneXpert® System, the world's
leading molecular platform for accuracy, speed, and
ease-of-use.
Up to 93% of hospital-acquired SA infections are caused by a
patient's own colonized flora, making SA nasal carriers nearly 9
times more likely to develop surgical site infections (SSIs) than
non-carriers.(1,2) Nasal carriage of SA is also a major risk factor
for self-infection in dialysis, ICU and burn patients.(2,3,4)
"The availability of an accurate and rapid SA/MRSA test should
help to improve clinicians' efforts to prevent and control
Healthcare Associated Infections (HAIs) identified with colonized
patients. HAIs in general are responsible for nearly $30 billion in associated healthcare expenses in
the US each year," said John Bishop,
Cepheid's Chief Executive Officer. "Surgical, trauma, burn and
dialysis patients are most at risk for serious complications from
SA infections, which lead to approximately 12,000 inpatient deaths
annually in the US."(1)
US hospitals continue to struggle with the rising costs
associated with management of HAIs — estimated at $9.5 billion for SA and $20 billion for MRSA annually.(5,6) A recent
multicenter study, published in the New England Journal of
Medicine, demonstrated that a program employing rapid molecular
detection of SA colonization, followed by targeted decolonization,
resulted in a 60% reduction in SSIs.(7)
"A rapid test for both SA and MRSA will have many applications
for patients at risk of colonization," said Samir S. Awad MD, FACS, Associate Professor of
Surgery, Chief, Section of Critical Care, Baylor College of Medicine. "Those applications
include assisting physicians in targeting appropriate prophylactic
therapy and decolonization to reduce the risk of post-surgical site
infections."
Xpert SA Nasal Complete is Cepheid's tenth test to receive FDA
clearance, and sixth in its expanding menu of industry-leading HAI
products. Xpert SA Nasal Complete will be available for shipment
this month. Visit www.cepheid.com for Cepheid's entire portfolio of
molecular diagnostic products.
About the GeneXpert® System Molecular Diagnostic
Platform
The GeneXpert System is a closed, self-contained,
fully-integrated and automated platform that represents a paradigm
shift in the automation of molecular analysis, producing accurate
results in a timely manner with minimal risk of contamination. The
GeneXpert System is the only system to combine on-board sample
preparation with real-time PCR (polymerase chain reaction)
amplification and detection functions for fully integrated and
automated nucleic acid analysis. The system is designed to purify,
concentrate, detect and identify targeted nucleic acid sequences
thereby delivering answers directly from unprocessed samples.
Modular in design, the GeneXpert System has a variety of
configurations to meet the broad range of testing demands of any
clinical environment.
About Cepheid
Based in Sunnyvale, Calif.,
Cepheid (Nasdaq: CPHD) is an on-demand 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; and identifying bio-terrorism agents
in the biothreat market. See http://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 changes or
developments; practices regarding testing timing and frequency;
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 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.
References
- Critchley et al, Drug Discovery Today, 2006, Vol. 3 No. 2
- VL Yu et al., "Staphylococcus aureus nasal carriage and
infection in patients on hemodialysis. Efficacy of antibiotic
prophylaxis." NEJM July
1986
- Mackie et al, "Reduction in Staphylococcus aureus wound
colonization.", Burns 1994; 20, (1), S14-S18
- Kooistra-Smid et al, "Molecular epidemiology of Staphylococcus
aureus colonization in a burn center", Burns 2004, Feb; 30 (1),
27-33
- Noskin, Infection Control Hospital Epidemiology, 2008, Vol. 29,
No. 1
- Saadatian-Eliahi et al, International Journal of Surgery, 2007,
Vol. 6, Issue 3
- Bode et al, "Preventing Surgical-Site Infections in Nasal
Carriers of Staphylococcus aureus", NEJM January 2010
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
jared.tipton@cepheid.com
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Jacquie Ross
Cepheid Investor Relations
408-400-8329
investor.relations@cepheid.com
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SOURCE Cepheid