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Cepheid Receives Health Canada License for First On-demand Diagnostic Test for Life-threatening MRSA and S. aureus Infections From Patient Positive Blood Culture Bottles

Posted on: Wednesday, 11 March 2009, 06:00 CDT

Physician Access to Critical Test Results Improved by More Than Twenty-Four Hours Over Conventional Methods

SUNNYVALE, Calif., March 11 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD) today announced that Health Canada has issued a medical device license for its Xpert(R) MRSA/SA Blood Culture (BC) test for the rapid detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA, typically Methicillin-sensitive) in blood culture bottles showing gram-positive cocci. With results reporting in less than one hour, Cepheid's Xpert MRSA/SA BC test was designed to empower physicians with a new tool to aid in selecting the most effective antibiotic therapy to improve patient management and outcomes.

"Xpert MRSA/SA BC results enable physicians to initiate targeted therapy in septic patients far sooner than current culture-based methods - an important advancement in the timely management of potentially life-threatening infections," said Rob Koska, Cepheid's Senior Vice President of Worldwide Commercial Operations. "With the addition of our Xpert MRSA/SA Blood Culture diagnostic test, Canadian institutions are now armed with another tool in the armamentarium for the rapid detection of MRSA and SA and overall management of infections."

Cepheid's Xpert MRSA/SA BC test processes positive blood culture specimens to determine if a patient's blood is infected with MRSA or SA, which are frequent causes of sepsis in hospitalized patients. This can enable physicians to quickly de-escalate from broad-spectrum antibiotic treatment to a more effective targeted therapy, thus reducing risk of resistance and improving patient outcomes.

Typically, physicians will order a set of blood culture bottles drawn from patients presenting with symptoms of systemic infections. Positive cultures can appear in as little as 6-24 hours, but then require further testing to identify the specific organism causing the infection. Currently, those additional tests -- most notably to determine if the organism is methicillin-resistant or methicillin-susceptible Staphylococcus aureus -- are done via slower culture testing methods.

"Same day diagnostic results for blood culture bottles growing gram-positive cocci will empower physicians to begin targeted therapy in septic patients far sooner than current culture-based methods," said Dr. Ellen Jo Baron, Director of Clinical Microbiology and Virology Laboratories for Stanford University Hospital and Director of Medical Affairs at Cepheid. "These results, delivered 24-48 hours sooner, can potentially improve antibiotic stewardship and provide patients with the best, most effective therapeutic regimen."

MRSA and SA infections are national medical concerns that place millions of lives at risk and add millions of dollars to healthcare costs each year -- both in outpatient, or community-acquired infections, and in-patient, or surgical site infections acquired within the healthcare environment. According to a recent six-year Queens University study, published in the December 2008 issue of the American Journal of Infection Control, more than 250,000 Canadian patients experience infected surgical wounds, blood infections, and antibiotic resistant organisms while in the hospital each year. The study also states that, since 1999, rates of MRSA have more than doubled -- from 2 to 5.2 per 1,000 hospital admissions across Canada.

Xpert MRSA/SA BC is Cepheid's sixth test to receive a Health Canada Medical Device License.

About the GeneXpert(R) System Molecular Diagnostic Platform

The GeneXpert(R) 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; 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 product performance and future market opportunities in Canada. 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 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 408-400-8377 408-400-8329 jared.tipton@cepheid.com jacquie.ross@cepheid.com

SOURCE Cepheid

Source: PR Newswire

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