Cepheid, Sunnyvale, Calif, has received FDA approval for its Xpert® MTB/RIF test for the rapid molecular detection of Mycobacterium tuberculosis complex (MTB-complex) DNA and, in specimens where MTB-complex DNA is detected, to detect rifampin-resistance associated mutations of the rpoB gene.
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.
“With results available to clinicians in approximately 2 hours instead of weeks, the dramatic impact of Xpert MTB/RIF on identifying TB positive patients and optimizing their drug therapy has been well documented outside of the US,” says John Bishop, chairman and CEO, adding that US clinicians can also leverage those same results for detecting whether the strain may be multidrug-resistant, requiring more intensive drug therapy.
Designed for use on Cepheid’s GeneXpert Systems, the test also detects the presence of 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 (MDR-TB).
Patients with multidrug-resistant TB need more intensive and prolonged therapy. The test will enable US clinicians to 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, according to the company.
The symptoms of TB in its early stages are similar to many different types of infections.While TB in the United States is at its lowest level since 1953, rapid and accurate diagnosis of TB continues to be a challenge, especially among immunocompromised patients and the elderly.
[Source: Cepheid]
