SUNNYVALE, Calif., June 27 /PRNewswire-FirstCall/ -- Cepheid (NASDAQ:CPHD), a broad-based molecular diagnostics company, today announced the European release of the Smart CMV(TM) (cytomegalovirus) Assay for clinical diagnostic use on the SmartCycler(R) System. The CMV assay was released as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices.
Smart CMV is intended for rapid detection and quantitation of CMV viral load. CMV is a member of the herpes virus family, which includes the herpes simplex viruses and the viruses that cause chicken pox (varicella-zoster virus) and infectious mononucleosis (Epstein-Barr virus). Most CMV infections are asymptomatic and often lead to undetected, latent infection and re-infection. However, among immunocompromised patients such as organ transplant recipients, AIDS and cancer patients, CMV infection is a significant cause of disease and mortality.
Detection of active CMV infection plays a critical role in diagnosis and treatment. Periodic monitoring of CMV viral load in consecutive clinical samples is used to identify high-risk patients and to monitor their response to CMV therapy. Because of their specificity and sensitivity, real-time PCR diagnostics like Smart CMV are an important tool in the effective clinical management of CMV patients.
"Cytomegalovirus (CMV) is an important pathogen in immunosuppressed patients, including organ transplant recipients and AIDS patients. The clinical utility of quantitative CMV DNA tests in managing these patient groups has been well documented," said Professor Mario Poljak, MD, Ph.D., Head of the Laboratory for Molecular Microbiology and Head of Slovenian AIDS Reference Centre at the Medical Faculty of Ljubljana in Slovenia. "In transplant recipients, CMV load is used to diagnose active CMV disease, screen patients for the use of preemptive therapy, and monitor the response to antiviral therapy. In patients infected with human immunodeficiency virus type 1, the risk of developing CMV disease has been reported to be directly related to the quantity of CMV DNA in plasma."
"Smart CMV is the sixth in a planned menu of CE IVD Mark products launching into the European market this year, and the third product in our expanding portfolio for use in the management of immunocompromised patients," said Cepheid Chief Executive Officer John Bishop. "Cepheid's scaleable SmartCycler(R) and GeneXpert(R) technologies are making it easier and cost effective for institutions of any size to reap the benefits of molecular diagnostics."
The SmartCycler(R) System is a leading real-time PCR testing platform for hospitals, university research labs and government agencies. By automating the amplification and detection process, the SmartCycler(R) System can deliver highly accurate and consistent test results from prepared biological samples in approximately 30-40 minutes. With up to 96 independently programmable reaction sites, the SmartCycler(R) System can simultaneously run different tests with different protocols and at different times. This eliminates complex advanced scheduling on larger, more costly systems as well as the need to transport samples to central facilities for analysis.
Cepheid (NASDAQ:CPHD), based in Sunnyvale, California, is a 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 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 timing of product shipments and expansion 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: development and manufacturing problems; our ability to successfully obtain regulatory approvals and introduce new products in the clinical market; customer acceptance of new products; 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; 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 2005 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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