FDA Categorizes Cepheid's Xpert MTB/RIF Test As 'Moderate Complexity'

(RTTNews) - Cepheid (CPHD) announced the U.S. FDA has categorized Cepheid's Xpert MTB/RIF test as 'Moderate Complexity' under the Clinical Laboratory Improvement Amendments. The test runs on Cepheid's GeneXpert Systems.

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.

"The 'Moderate Complexity' categorization of Xpert MTB/RIF will allow a broad range of healthcare facilities access to actionable results in approximately 2 hours instead of weeks," said John Bishop, Cepheid's Chairman and Chief Executive Officer.