Cepheid, a California-based medical device firm, has received market authorization from the US Food & Drug Administration (FDA) for its Xpert MTB/RIF test, a tuberclosis test.
The regulatory agency approved following a de novo 510(k) review process, which allows new products without predicates to be down-classified and brought to market.
Xpert MTB/RIF is meant for quick molecular detection of Mycobacterium tuberculosis complex (MTB-complex) DNA.
In cases where MTB-complex DNA has been detected, Xpert MTB/RIF can find out rifampin-resistance associated mutations of the rpoB gene.
Cepheid chairman and CEO John Bishop said that with results available to clinicians in approximately two hours instead of weeks, the 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.
It is designed to be used on Cepheid's GeneXpert Systems.
Multidrug-resistant TB cases require not only intensive but also prolonged therapy and Xpert MTB/RIF is claimed to provide quick results that help in taking decision on what kind of therapy is needed early in the course of disease, and not wait for six weeks as is the case when the tests are done with regular conventional lab methods.
Tuberculosis is a major global health concern. About 8.7 million new cases were reported worldwide in 2011, according to the WHO estimates.