Cepheid receives Health Canada medical device license for Xpert MRSATM test and GeneXpertR system

January 29, 2008 — /PrNewswire/ — SUNNYVALE, CA — Cepheid (NASDAQ:CPHD) today announced that Health Canada has issued a medical device license for the XpertTM MRSA test for the rapid detection of Methicillin-Resistant Staphylococcus aureus (MRSA) on nasal swabs and the GeneXpertR 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,” says Cepheid CEO 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, CA, 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.

Visit www.cepheid.com


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