Cepheid Expands Menu of CE IVD Products Available in Europe With Introduction of Xpert GBS(TM) Test for GeneXpert(R) System
Monday April 3, 7:00 am ET
GeneXpert System to Help Enable 24/7 On-Demand Molecular GBS Testing; Physicians Can Rapidly Diagnose GBS Colonization at Time of Delivery or 35-37 Weeks
SUNNYVALE, Calif., April 3 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD - News), a broad-based molecular diagnostics company, today announced the European release of the Xpert GBS(TM) (Group B Streptococcus) test for clinical diagnostic use on the GeneXpert® System. The GBS assay was released as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. Xpert GBS is intended for rapid detection of GBS in antepartum and intrapartum women, producing results in just over an hour.
According to the Centers for Disease Control and the World Health Organization, GBS is the leading infectious cause of neonatal morbidity and mortality. It 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. Use of Xpert GBS can aid in the rapid detection and subsequent determination of proper treatment of GBS-colonized women in order to reduce potential transmission of the disease-causing organism to their newborns. The use of the Xpert GBS can also potentially reduce unnecessary antibiotic use in those not colonized with the bacteria.
"The current standard of care-testing via culture-does not provide clinicians with answers in an optimal timeframe to make the best treatment decisions," said Pierrette Melin, Ph.D., Associate Professor, Director of the Belgian Group B Strep Reference Laboratory. "Having rapid results from Xpert GBS available 24 hours a day, 7 days a week will help ensure better care for mothers and newborns."
The GeneXpert System provides significant advantages in sensitivity and ease of use over the company's existing SmartCycler® System based tests currently on the European market. The GeneXpert System, a closed, self-contained, fully-integrated and automated system, represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination.
"The Xpert GBS test is the second in a planned menu of CE IVD Mark products scheduled to be released in Europe for use on the GeneXpert System during 2006," said Cepheid Chief Executive Officer John Bishop. "As noted, the GeneXpert System represents a major paradigm shift in the automation of molecular diagnostics and we expect it to be particularly useful in the clinical market providing user benefits and application benefits with a system flexible enough to meet the diverse needs of the clinical community ranging from hospital and reference labs, to satellite labs and physician's office labs."
The GeneXpert® System was released in the Biothreat market in 2004 and has subsequently been proven to be an extremely robust and accurate platform technology with over 1,300 modules and systems on the market generating over 2.3 million anthrax test results. The GeneXpert System is configurable with anywhere from 1 to 16 independently operated modules, allowing users to perform multiple molecular diagnostic tests simultaneously.
About Cepheid
Cepheid (Nasdaq: CPHD - News), 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. |
