Cepheid Xpert TB Test Gets CLIA 'Moderately Complex' Rating | GenomeWeb

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.

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