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US FDA Categorizes Cepheid’s Xpert MTB/RIF test as ‘moderate complexity’

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 test is designed for the rapid molecular detection of Mycobacterium tuberculosiscomplex (MTB-complex) DNA and, in specimens where MTB-complex DNA is detected, it also detects rifampin-resistance associated mutations of the rpoB gene.

The test runs on Cepheid’s GeneXpert systems and is reportedly the first molecular TB (tuberculosis) test to be categorized as moderately complex.

This categorization of Xpert MTB/RIF will allow a broad range of healthcare facilities access to actionable results in approximately two hours instead of weeks.

Cepheid chairman and CEO John Bishop said 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.

"Now, U.S. clinicians can leverage those same transformative results not only for the detection of TB (tuberculosis), but also for detecting whether the strain may be multidrug-resistant, requiring more intensive drug therapy," Bishop added.

Xpert MTB/RIF, which is designed for use on Cepheid’s GeneXpert systems, not only detects the presence of MTB-complex DNA, but also mutations associated with resistance to rifampin.

Rifampin is a reliable surrogate marker of strains that may be multidrug-resistant TB and a critical first-line drug for treatment of the disease.

Xpert MTB/RIF will allow US clinicians to significantly improve patient outcomes by providing rapid results that guide therapy decisions early in the course of disease compared to traditional methods.

It is also expected to help eliminate guesswork and deliver maximum medical value in the management of TB in the US.