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FDA Clears Expanded Claims for Cepheid TB Test

NEW YORK (GenomeWeb) – The US Food and Drug Administration has cleared expanded claims for Cepheid's Xpert MTB/RIF test, the company said today.

The test detects Mycobacterium tuberculosis complex DNA, Cepheid said, adding it also simultaneously detects mutations associated with rifampin-resistance in the rpoB gene. With the expanded product claim, clinicians will be able to use one or two negative Xpert MTB/RIF tests results together with other clinical and laboratory data to remove patients from airborne infection isolation, or respiratory isolation, the Sunnyvale, Calif.-based firm said. 

The test runs on Cepheid's GeneXpert platform and received de novo 510(k) clearance in July 2013. 

The test generates results in two hours, enabling clinicians to end respiratory isolation precautions without having to wait days or weeks to get back negative smear tests, Cepheid Chief Medical and Technology Officer David Persing said in a statement. "The ability to quickly differentiate patients that require TB respiratory isolation from those that do not pose a risk of transmitting TB will allow hospitals to focus their infection control efforts where they can have the greatest impact," he said.