Cepheid Reports Xpert MTB/RIF Categorized 'Moderate Complexity' by FDA

Cepheid

today announced the U.S. Food & Drug Administration (FDA) has categorized Cepheid's Xpert^® MTB/RIF test as 'Moderate Complexity' under the Clinical Laboratory Improvement Amendments (CLIA). Xpert MTB/RIF is designed for the rapid molecular detection of Mycobacterium tuberculosis complex (MTB-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 test runs on Cepheid's GeneXpert^® Systems and is the first and only molecular TB (tuberculosis) test to be categorized as Moderately Complex.