Tuberculosis test, 9/13

Cepheid has received FDA market authorization for its Xpert MTB/RIF test, which provides results in about two hours. The review decision was based on the de novo 510(k) review process, which allows novel products without predicates to be downclassified and brought to market. Xpert MTB/RIF is 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-resistant associated mutations of the rpoB gene.

Designed for use on Cepheid’s GeneXpert systems, Xpert MTB/RIF detects MTB-complex DNA and also mutations associated with resistance to rifampin, a critical first-line drug for treatment of the disease and a reliable surrogate marker of strains that may be multidrug-resistant. Xpert MTB/RIF will enable U.S. clinicians to significantly improve patient outcomes by providing rapid test results to guide therapy decisions early in the course of disease.

“Xpert MTB/RIF is the most technologically advanced test for TB ever developed, yet it is simple enough to be performed across multiple shifts in laboratories across the country,” David H. Persing, MD, PhD, Cepheid’s chief medical and technology officer, said in a statement. “About one-third of the human population is infected with TB, but most do not have active disease that requires treatment. Ruling out active disease in TB suspects is a relatively common task of domestic clinical laboratories. We think that the Xpert MTB/RIF test will help to eliminate guesswork and deliver maximum medical value in the management of TB here in the U.S., as already demonstrated abroad.”

Cepheid, 408-541-4191