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Cepheid Receives FDA Clearance For Xpert vanA

Cepheid has received clearance from the FDA to market Xpert vanA, the rapid and accurate test released in the US for vanA. The 45-minute test runs on GeneXpert System, a healthcare-associated infections (HAI) molecular testing platform

The company said that VanA is the antimicrobial resistance gene associated with vancomycin-resistant enterococci (VRE), a major healthcare-associated infection.

The US Centers for Disease Control and Prevention reports that 30% 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.

John Bishop, chief executive officer of Cepheid, said: “As encountered with other HAI-associated pathogens, the lack of a rapid and accurate test for vanA has impacted clinicians’ efforts in the recognition, prevention and control of VRE.

“Xpert vanA should be a aid in helping to address this clinical need with fast and accurate test results that can be available on a 24/7 basis. The availability of Xpert vanA adds an additional dimension to the molecular portfolio of test products for management of HAIs on the market.”

David Persing, chief medical and technology officer at Cepheid, said: “Many patients in the areas of oncology, hematology, nephrology, transplant and abdominal surgery units are at highest risk for contracting VRE. Therefore, it’s imperative to prevent potential outbreaks by testing for vanA upon admission of high risk patients.

“Several recent studies have demonstrated that a policy of recognition, prevention and control of vancomycin-resistant organisms that colonize patients in healthcare settings can lead to a reduction in transmission rates. A rapid PCR test mitigates perceived drawbacks to preemptive isolation and maximizes medical value by delivering actionable results almost immediately.”