NEW YORK (GenomeWeb News) – Cepheid said today that the US Food and Drug Administration has categorized Cepheid's Xpert MTB/RIF test as "moderate complexity" under CLIA guidelines.
Xpert MTB/RIF runs on Cepheid's GeneXpert system and is designed for the rapid molecular detection of Mycobacterium tuberculosis complex DNA and rifampin-resistance associated mutations of the rpoB gene. The assay provides results in two hours, compared to up to three months with traditional methods of detecting drug-resistant TB, according to Cepheid.
The FDA granted de novo 510(k) clearance to Xpert MTB/RIF last month. Cepheid has been selling the assay outside the US for nearly two years under its high-burden developing country program.
The assay becomes the first and only molecular TB test to be categorized as CLIA moderately complex, said Cepheid.
"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," Cepheid Chairman and CEO John Bishop said in a statement. "Now, US clinicians can leverage those same transformative results not only for the detection of TB, but also for detecting whether the strain may be multidrug-resistant, requiring more intensive drug therapy."