Cepheid Receives FDA Market Authorization For Xpert MTB/RIF

(RTTNews) - Cepheid (CPHD) said Thursday that it has received market authorization from the U.S. Food & Drug Administration for its Xpert MTB/RIF test.

The review decision was based on the de novo 510(k) review process, which allows novel products without predicates to be down-classified and brought to market.

Xpert MTB/RIF is designed for the rapid molecular detection of Mycobacterium tuberculosis complex DNA and, in specimens where MTB-complex DNA is detected, Xpert MTB/RIF also detects rifampin-resistance associated mutations of the rpoB gene.

Designed for use on Cepheid's GeneXpert Systems, Xpert MTB/RIF not only detects the presence of MTB-complex DNA, but also mutations associated with resistance to rifampin, a critical first-line drug for treatment of the disease and a reliable surrogate marker of strains that may be multidrug-resistant.

Patients with multidrug-resistant TB need more intensive and prolonged therapy. Xpert MTB/RIF will enable U.S. clinicians to significantly improve patient outcomes by providing rapid results that guide therapy decisions early in the course of disease, not 6 weeks later as is the case with standard laboratory methods.

Xpert MTB/RIF is now available for immediate shipment in the U.S.