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Cepheid Gets FDA Nod for Antimicrobial Resistance Test

NEW YORK (GenomeWeb News) – Cepheid said today that it has received clearance from the US Food and Drug Administration to market its Xpert vanA test for the antimicrobial resistance gene most commonly associated with vancomycin-resistant enterococci.

The 45-minute test runs on Cepheid's GeneXpert System, and is the first rapid and accurate test released in the United States for vanA, Cepheid said.

According to the US Centers for Disease Control and Prevention, some 30 percent of enterococcal healthcare-associated infections are due to vancomycin-resistant enterococci. Such infections have been shown to increase patient length of stays, mortality rates, and unnecessary use of antibiotics, leading to higher costs for healthcare institutions.

"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," Cepheid CEO John Bishop said in a statement. "Xpert vanA should be a significant aid in helping to address this clinical need with fast and accurate test results."

Cepheid said that Xpert vanA will be available for shipment this month, and that it is the ninth of its tests to receive FDA clearance, and fifth in its portfolio of HAI products.

Earlier this week, Cepheid said that the FDA had granted an Emergency Use Authorization for the firm's Xpert Flu A Panel test, which can identify the 2009 H1N1 influenza virus in less than one hour, according to the company.

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