The FDA has granted marketing approval for Xpert MTB/RIF Assay, the first FDA-reviewed test that can simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria contain genetic markers that makes them resistant to rifampin.

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

Patients with multidrug-resistant TB (MDR-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. 

Test results, including the detection of TB bacteria and whether the bacteria are drug resistant, are available in approximately two hours.

The Xpert MTB/RIF Assay is manufactured and marketed by Cepheid.

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