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Cepheid Gets FDA Green Light for C. Difficile Test

NEW YORK (GenomeWeb News) – Cepheid today said that it has received clearance from the US Food and Drug Administration to market its Xpert C. difficile test.

The Sunnyvale, Calif.-based molecular diagnostics firm said the test is designed to provide results in 45 minutes. It detects the bacterium that causes Clostridium difficile infection, a prevalent healthcare-associated infection.

"A rapid, accurate CDI test will eliminate needless repetitive testing and enable us to implement appropriate treatment and infection control measures faster in our battle against this devastating healthcare-associated infection," Dale Gerding, professor of medicine in the division of infectious diseases at Loyola University Chicago Stritch School of Medicine, said in a statement issued by Cepheid.

Cepheid said that the test targets the Toxin B gene, which was discovered in 1978 as the cause of antibiotic-associated diarrhea and colitis. "The Toxin B (tcdB) gene is the critical component of all toxigenic Clostridium difficile strains — including the epidemic 027/NAP1/BI strain," the firm said.

It added that it will continue to work closely with the FDA to deliver an additional test offering simultaneous differentiation of the 027/NAP1/BI epidemic strain.

The C. diff test runs on Cepheid's GeneXpert System, and the firm will begin shipments next week.

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