Cepheid CPHD 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.
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