SUNNYVALE, Calif., July 6 /PRNewswire-FirstCall/ -- Cepheid , a broad-based molecular diagnostics company, today announced the European release of the Smart GBS(TM) (Group B Streptococcus) test for clinical diagnostic use on the SmartCycler(R) System. The GBS test was released as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. Smart GBS is intended for rapid detection of GBS in antepartum and intrapartum women, producing results in about 60 minutes. GBS is a potentially fatal bacterial infection that can be passed from mother to child during birth causing neonatal GBS disease. This can result in neonatal sepsis, meningitis and pneumonia leading to sight or hearing loss, mental retardation or death.
“The Smart GBS test is the seventh test in a planned 2006 menu of CE IVD Mark products scheduled to be released in Europe for use on our SmartCycler and GeneXpert(R) platforms,” said Cepheid Chief Executive Officer John Bishop.
According to the Centers for Disease Control and the World Health Organization, GBS is one of the most important infectious causes of neonatal morbidity and mortality. The CE IVD Mark Smart GBS test uses polymerase chain reaction (PCR) to provide accurate, actionable results on Cepheid’s SmartCycler System -- in about one hour. If colonization is detected, expectant mothers can be treated with simple antibiotics. GBS-positive expectant mothers, if untreated at the time of delivery, are 20 times more likely of passing the disease to their newborns than those who are treated.
The existing standard of care, culture-based GBS testing, takes two to three days for results. If a woman enters labor with an unknown GBS status, clinicians are likely to treat the patient with antibiotics as a precautionary measure. Rapid results from Cepheid’s Smart GBS test can ensure the proper treatment of GBS colonized women, and may reduce unnecessary antibiotic use in women not colonized with the bacteria.
The SmartCycler 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 System can deliver highly accurate and consistent test results from prepared biological samples in approximately 30-60 minutes. With up to 96 independently programmable reaction sites, the SmartCycler System can simultaneously run multiple tests with different protocols and start times. This eliminates complex advanced scheduling on larger, more costly systems, as well as the need to transport samples to central facilities for analysis.
About Cepheid
Cepheid , based in Sunnyvale, Calif., 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, timing of product shipments and timing of 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.
CONTACTS: At the Company: John L. Bishop CEO, Cepheid 408-541-4191 john.bishop@cepheid.com John R. Sluis CFO, Cepheid 408-541-4191 john.sluis@cepheid.com At Financial Relations Board: Tricia Ross Investor/Analyst Information 617-520-7064 tross@financialrelationsboard.com At Schwartz Communications: Chris Stamm, Nigel Smith 781-684-0770 cepheid@schwartz-pr.com
Cepheid
CONTACT: John L. Bishop, CEO, john.bishop@cepheid.com, or John R. Sluis,CFO, john.sluis@cepheid.com, both of Cepheid, +1-408-541-4191; orInvestor/Analyst Information, Tricia Ross of Financial Relations Board,+1-617-520-7064, tross@financialrelationsboard.com, for Cepheid; or ChrisStamm or Nigel Smith, both of Schwartz Communications, +1-781-684-0770,cepheid@schwartz-pr.com, for Cepheid
Web site: http://www.cepheid.com//
