Healthcare Industry News: Real-Time PCR
News Release - December 4, 2007
Cepheid Launches New GeneXpert(R) Tests in Europe for Simultaneous, Rapid Detection of Staphylococcus Aureus and Methicillin Resistant Staphylococcus AureusTests for Skin and Soft Tissue Infection and Blood Culture Extend European Product Line for Healthcare Acquired Infections
SUNNYVALE, Calif., Dec. 4 (HSMN NewsFeed) -- Cepheid (Nasdaq: CPHD ) today announced the European release of Xpert(TM) MRSA/SA-Blood Cultures (BC) and Xpert(TM) MRSA/SA-Skin and Soft Tissue Infection (SSTI) tests as European CE IVD Mark products under the European Directive on In Vitro Diagnostic Medical Devices. The tests are designed to enable simultaneous rapid detection of two leading causes of hospital and community acquired infections -- Methicillin Resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA) -- directly from blood cultures and soft tissue infection samples respectively.
"The incidence of both hospital and community acquired MRSA and SA infections have been shown to be rapidly increasing. We believe that the unique ability of the GeneXpert System to provide test results on an on-demand basis in a short period of time may significantly aid in patient management," said Cepheid Chief Executive Officer John Bishop.
Both the Xpert MRSA/SA-SSTI and Xpert MRSA/SA-BC products deliver results in approximately 50 minutes, thereby enabling healthcare professionals to rapidly determine the presence or absence of MRSA and SA with a single test. In addition, both products employ a multiplex molecular protocol for potentially avoiding clinical false-positive MRSA results. While SA infections are generally treatable with common antibiotics, MRSA is resistant to numerous penicillin and cephalosporin antibiotics.
"Staphylococcus aureus is a major cause of bloodstream infection, associated with substantial mortality and healthcare cost. Its impact may be more severe in cases of infection caused by methicillin-resistant strains, which are more difficult to treat," said Professor Marc Struelens of the Catholic University Hospital, Brussels and Head of the Belgian Staphylococcal Reference Laboratory. "By analyzing positive blood cultures, we found the Xpert MRSA/SA test to be very reliable for rapid DNA-based detection and identification of S.aureus and MRSA bacteremia."
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 usage in the clinical diagnostics market. 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; customer market acceptance of the product; the failure of products to perform as expected, whether due to manufacturing errors, defects, incorrect operation or otherwise; issues related to regulatory review; 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.
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