Cepheid Gets FDA Clearance for Expanded Claims on TB Test

The FDA last week cleared the use of negative results from Cepheid’s Xpert MTB/RIF tuberculosis test to remove patients from respiratory isolation. The results must be considered with other laboratory and clinical data, the company said.

Xpert MTB/RIF detects mycobacterium TBcomplex DNA, and in positive specimens, identifies rifampin-resistant mutations of the rpoB gene. The test returns results in two hours, allowing clinicians to discontinue isolation precautions quickly instead of waiting the requisite days or weeks for negative smear tests — the standard TB testing method.

The ability to quickly distinguish patients who require TB isolation from those who don’t will allow hospitals to focus infection-control efforts where they are needed most, said David Persing, Cepheid’s chief medical and technology officer.

While the incidence of TB in the U.S. is low, the number of patients tested for exposure is still significant, the Sunnyvale, Calif., company said, adding that placing patients in respiratory isolation is expensive and can impede patient care.

The test runs on the Cepheid GeneXpert System. — Kellen Owings