Cepheid Gets FDA Clearance For Expanded Claims On Tuberculosis Test

(RTTNews) - Cepheid (CPHD) announced Friday that it has received clearance from the U.S. Food & Drug Administration or FDA for expanded claims on its Xpert MTB/RIF test.

Xpert MTB/RIF detects Mycobacterium tuberculosis complex (MTB-complex) DNA and in positive specimens, provides simultaneous identification of rifampin-resistance associated mutations of the rpoB gene.

The expanded product claim enables clinicians to use either one or two negative Xpert MTB/RIF test results, in conjunction with other clinical and laboratory data, to remove patients from airborne infection isolation (AII), commonly referred to as respiratory isolation. The test runs on the Cepheid GeneXpert System, the world's leading molecular diagnostic platform with over 8,000 systems deployed globally in both developed and emerging market countries.