FDA Permits Marketing of Test For Detecting Antibiotic-Resistant TB

The Food and Drug Administration July 25 said it allowed marketing of the first test that can simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria are resistant to certain antibiotics.

The Xpert MTB/RIF Assay is manufactured and marketed by Cepheid, of Sunnyvale, Calif.

According to FDA, the assay can detect if the TB bacteria contain genetic markers that makes them resistant to rifampin, an important antibiotic for treating TB. Traditional methods to detect drug-resistant TB usually require one to three months. Test results from the new assay, including the detection of TB bacteria and whether the ...