MRSA, GBS and EV Expand GeneXpert(R) Test Menu in Canada and Mexico
SUNNYVALE, Calif., June 3 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD) today announced that Health Canada issued a medical device license for Xpert(TM) GBS, for the rapid detection of Group B Streptococcus (GBS), and Xpert(TM) EV (enterovirus), for the rapid detection of EV-associated meningitis. These tests join Xpert MRSA, which received Health Canada license in January of this year. In Mexico, Cepheid has received registration from the Secretary of Health for its GeneXpert System and Xpert(TM) MRSA, Xpert GBS and Xpert EV tests. The products will be distributed exclusively through I.L. Diagnostics S.A. in Mexico and Fisher Scientific in Canada.
"Regulatory licenses and registrations are critical in our efforts to effectively penetrate these new markets," said Rob Koska, Cepheid's Senior Vice President, Worldwide Commercial Operations. "Both Canada and Mexico will now have access to all of these high medical value-added diagnostic products that are improving patient care throughout the world."
As is the situation in the United States, MRSA is a growing public health concern in Mexico. According to a study published in the Journal of Clinical Microbiology, "The prevalence of resistant bacteria has been increasing rapidly in Mexican hospitals during the last few years. According to different studies performed in the 1980s, 1990s, and 2000, the prevalence of MRSA in Mexican hospitals was estimated to vary from 7 to 30%." Rapid MRSA test results continue to be the cornerstone of the world's most effective surveillance programs.
GBS is a common cause of life-threatening infection in newborns worldwide. According to the Centers for Disease Control (CDC), there are still over 1500 annual cases of early onset GBS in the U.S. -- despite current testing guidelines which recommend screening between 35 and 37 weeks of gestation. However, this does not protect against the bacterial population changing in the weeks preceding delivery, nor does it help women who go into pre-term labor. Xpert GBS is uniquely positioned to yield test results in about an hour, where standard culture-based testing may take several days. The Xpert GBS test allows doctors to make a prompt treatment decision, making it an extremely useful tool in the intrapartum period preceding delivery.
Enterovirus, the cause of viral meningitis, is not a life-threatening disease and typically self-resolves in less than 10 days. However, bacterial meningitis (caused by a bacterial infection) is potentially fatal. As patients present with meningitis symptoms, the need for a test to differentiate between the two conditions is critical. Traditional tests take days to provide results, whereas the Xpert EV test can provide physicians with results in about two and a half hours. With rapid EV results, physicians are able to make better patient management and treatment decisions.
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.
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 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.
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