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Cepheid Gets European OK for VRE Test

NEW YORK (GenomeWeb News) – Molecular diagnostics firm Cepheid today said that it has received the CE Mark for its test that rapidly identifies the vanA and/or vanB genes, which are most commonly associated with vancomycin-resistant Enterococci.
 
The Sunnyvale, Calif.-based firm also said that it has launched the Xpert vanA/vanB test, which provides results in 45 minutes and runs on the company’s GeneXpert System. It is the first test developed and manufactured by Cepheid’s Swedish subsidiary, Cepheid AB.
 
The test will compete with another molecular diagnostic test, the BD GeneOhm VanR assay, which also detects vanA and vanB genes and is sold by Becton Dickinson. BD received the CE Mark for its test earlier this year.
 
Cepheid cited figures from the European Antimicrobial Resistance Surveillance System showing that VRE outbreaks increased in Europe from 3.3 percent in 2001 to 7.8 percent in 2004. Immunocompromised patients are at particular risk for VRE infections, which can cause wound, urinary tract, and intraabdominal infections, in addition to bacteremia and endocarditis.
 
“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,” Fred Tenover, senior director of scientific affairs at Cepheid, said in a statement.