Cepheid Announces CE IVD Release of First On-Demand Test for Van A/Van B Genes Most Associated With Hospital-Acquired VRE Infection
SUNNYVALE, Calif., Oct. 7 /PRNewswire-FirstCall/ — Cepheid today announced the release of Xpert(TM) vanA/vanB as a European CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. The test delivers rapid detection of vanA and/or vanB genes, the genes most commonly associated with vancomycin-resistant enterococci (VRE) — one of the more serious healthcare acquired infections (HAIs) worldwide. The 45-minute test runs on Cepheid’s GeneXpert(R) System, the world’s leading HAI molecular platform, and is the first test developed and manufactured by Cepheid AB in Bromma, Sweden.
“A rapid test for detection of drug resistance genes associated with VRE has the potential to significantly improve the way hospital surveillance is done for this group of organisms,” said Dr. Fred Tenover, Ph.D., Senior Director of Scientific Affairs at Cepheid. “Conventional tests that require microbial growth on selective media allow too much time for VRE transmission to occur before culture results become available to infection control practitioners, which limits the effectiveness of patient isolation strategies.”
According to the European Antimicrobial Resistance Surveillance System, VRE outbreaks have increased dramatically in Europe from 3.3 percent in 2001 to 7.8 percent in 2004. A 2002 German prevalence-rate study showed 0.7 percent colonization in the general population and 7.8 percent colonization in hospitals.
Immunocompromised patients are at highest risk for contracting VRE — especially in the areas of oncology, hematology, nephrology, transplant and abdominal surgery units. Patients with compromised immune systems are particularly susceptible to VRE infections that can cause wound, urinary tract and intraabdominal infections, in addition to bacteremia (blood infection) and endocarditis (inflammation of the heart).
“Xpert vanA/vanB is designed to aid physicians in the recognition, prevention and control of VRE in healthcare settings,” said Robert Koska, Cepheid’s Senior Vice President of Worldwide Commercial Operations. “Many studies have identified the recent rise in VRE outbreaks and prevalence rates — both in the U.S. and Europe. This test quickly identifies vanA/vanB carriers so clinicians can make rapid infection control decisions to prevent a possible outbreak.”
The U.S. Centers for Disease Control and Prevention reports that 30 percent of enterococcal HAIs are due to VRE. HAI infections have proven to increase patient length of stays, mortality rates and unnecessary use of antibiotics — leading to dramatically higher costs for healthcare institutions.
Healthcare workers, after contact with asymptomatic colonized patients, may spread VRE to other patients within hospitals. VRE can also be spread directly to people after contacting surfaces that are contaminated with the pathogen.
About the GeneXpert(R) System 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 is an on-demand molecular diagnostics company that develops, manufactures, and markets fully- integrated systems and tests 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. 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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