Published: September 26, 2008
California Legislation Highlights Need for Broad Menu of Tests in Growing Healthcare Acquired Infection Market
SUNNYVALE, Calif., Sept. 26 /PRNewswire-FirstCall/ -- Cepheid
(Nasdaq: CPHD) today announced that the new California Medical Facility
Infection Control and Prevention Act, aimed at reducing healthcare acquired
infections (HAIs), calls attention to the need for a comprehensive menu of
surveillance and diagnostic products in the growing HAI market.
HAIs continue to be a national healthcare concern. According to the U.S.
Centers for Disease Control and Prevention, in 1974 Methicillin-resistant
Staphylococcus aureus (MRSA) infections accounted for two percent of the total
number of staph infections. In 1995 that number had grown to 22 percent, and
by 2004 that number had further increased to 63 percent.
"California will be the fifth state to mandate active MRSA surveillance
and testing for patients hospitalized for certain procedures," said John
Bishop, Cepheid's Chief Executive Officer. "This new legislation demonstrates
the need for a portfolio of HAI testing products to address this rapidly
growing market. As the HAI testing leader, Cepheid is committed to delivering
products and services to help healthcare facilities implement effective HAI
testing programs."
California SB 1058, signed into law by Governor Schwarzenegger on
September 25th, will require hospitals to test certain patients for MRSA
within the first 24 hours of hospitalization. In addition, hospitals will have
to report, on a quarterly basis, incident rates of HAIs, including MRSA,
Vancomyacin-Resistant Enterococci (VRE), and Clostridium difficile (C.
difficile).
Cepheid's 2008 and 2009 menu of HAI products includes current and planned
GeneXpert(R) System tests for MRSA surveillance, MRSA skin and soft tissue,
MRSA positive blood culture samples, VRE, and C. difficile. These products
continue to position Cepheid with the most comprehensive HAI testing menu
available.
HAI Reduction is a Priority at the Federal Level
Dr. Don Wright, the Principal Deputy Assistant Secretary for Health for
the U.S. Health and Human Services Department (HHS) recently reiterated HHS'
commitment to reducing HAIs, by discussing his five point strategy to address
the growing HAI problem.
Starting October 1st, 2008, Centers for Medicare & Medicaid Services (CMS)
will no longer pay for the added costs of complications arising from certain
hospital-acquired conditions, including catheter associated urinary track
infections, vascular catheter associated infection, and certain surgical site
infections (mediastinitis after coronary artery bypass graft, certain
orthopedic procedures and certain bariatric surgery for obesity). A portion of
these infections can be caused by MRSA.
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 inSunnyvale, 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; food,
agricultural, and environmental testing in the industrial 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 future
products, 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 delays in clinical studies or in regulatory approvals; regulatory
developments and evolving best practices regarding testing levels; customer
and market acceptance of the product; unforeseen manufacturing problems; 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 market conditions worldwide. Readers should also
refer to the section entitled "Risk Factors" in Cepheid's Annual Report on
Form 10-K for 2007 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.
CONTACTS:
For Media Inquiries:
Jared Tipton
Cepheid Corporate Communications
408-400-8377
jared.tipton@cepheid.com
For Cepheid Investor Inquiries:
Jacquie Ross
Cepheid Investor Relations
Tel: (408) 400 8329
jacquie.ross@cepheid.com
SOURCE Cepheid
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