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Cepheid Announces CE IVD Release of First On-Demand Test for van A/van B Genes Most Associated With Hospital-Acquired VRE Infection
Date:10/7/2008

CE IVD Menu Expanded to Eight On-Demand Tests for Use on the GeneXpert(R)

System

SUNNYVALE, Calif., Oct. 7 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD) 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
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