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FDA Clears Cepheid's C. Difficile Test

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration today announced it has cleared Cepheid's Clostridium difficile test, making it the second C. difficile test from the company to receive such regulatory approval.

The Cepheid Xpert C. difficile/Epi assay is designed to rapidly detect the Toxin B gene associated with C. difficile infection and runs on the firm's GeneXpert platform. The automated assay detects the bacteria in stool samples and whether it is the epidemic 027/NAP1/BI strain, which has been associated with a marked increase in the incidence and severity of C. difficile infection in North America and Europe during the past decade, FDA said.

The test is for use in the aid of the diagnosis of C. difficile and is for epidemiological purposes only, FDA said. It should not be used to determine or monitor treatment.

The assay is the second from Cepheid to receive FDA clearance for C. difficile. In 2009 the agency gave the OK to another Cepheid test that also targets the Toxin B gene. The one cleared today, however, offers simultaneous differentiation of the 027/NAP1/BI epidemic strain.

Last month the FDA also cleared Meridian Bioscience's illumigene C. difficile test for pediatric use. Before that the test was cleared for use on non-pediatric patients.

"Health care professionals in the infectious disease community who have seen various outbreaks of [C. difficile infection] associated with aggressive strains in recent years now have a new testing tool to detect this disease," Alberto Gutierrez, director of the Office of In Vitro Diagnostics Device Evaluation and Safety in the FDA's Center for Devices and Radiological Health, said in a statement today.