The U.S. Food and Drug Administration (FDA) recently allowed marketing of the Xpert MTB/RIF assay, the first FDA-reviewed test that can simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria contain genetic markers that make them resistant to rifampicin, one of the most used first-line drugs for the treatment of TB.
The FDA reviewed the Xpert MTB/RIF assay through the de novo classification process, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device. In support of the de novo petition the manufacturer submitted data that included an assessment of the test’s accuracy in identifying the TB bacteria and the rifampicin-resistant strains as compared to validated test methods.