SUNNYVALE, Calif., Oct. 7 — 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 (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.