Cepheid Receives Health Canada Medical Device License For Xpert MRSA(TM) Test And GeneXpert(R) System

Main Category: MRSA / Drug Resistance
Also Included In: Medical Devices / Diagnostics;  Regulatory Affairs / Drug Approvals
Article Date: 30 Jan 2008 - 0:00 PDT

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Cepheid (Nasdaq: CPHD) announced that Health Canada has issued a medical device license for the Xpert(TM) MRSA test for the rapid detection of Methicillin Resistant Staphylococcus aureus (MRSA) on nasal swabs and the GeneXpert(R) System. Xpert MRSA test results are available in approximately 70 minutes thereby enabling rapid identification of carriers of the potential pathogen in less than two hours, from the acquisition of the patient sample to returning the result to the floor. The availability of the Xpert MRSA test and the GeneXpert System is expected to help enable Canadian healthcare organizations to implement more efficient infection control measures, leading to lower hospital acquired infection rates and improved patient care.

As is the situation in the United States, MRSA is a growing public health concern in Canada. According to a study published in the Canadian Journal of Infectious Diseases and Medical Microbiology the rate of MRSA in Canadian hospitals has increased steadily between 1995 and 2004. Patients with MRSA require prolonged hospitalization extending 26 days on average, special control measures, expensive treatments and extensive surveillance.

"There is evidence of growing worldwide concern over increasing MRSA infection rates and other Healthcare Acquired Infections such as Clostridium difficile. We expect to see more countries moving toward initiation of active surveillance programs," said Cepheid Chief Executive Officer John Bishop. "The GeneXpert System is uniquely positioned to enable organizations to provide fast, reliable MRSA test results 24 hours a day, seven days a week."

Canadian infection control officers have recommended that hospitals make prevention of healthcare acquired infections a patient safety priority, and should commit adequate resources to screening and implementation of other preventative measures. According to the March 2007 Ontario Provincial Infectious Disease Advisory Committee (PIDAC) recommendations, high-risk patients, as well as other patients as defined by local epidemiology and risk factors, should be actively screened for MRSA.

Xpert MRSA is Cepheid's second test to receive Health Canada license, following Smart GBS in October of 2007.

About the GeneXpert 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 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 and market size. 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 levels; 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 market conditions worldwide. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K for 2006 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.

Cepheid
http://www.cepheid.com