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FDA allows marketing for assay to detect TB bacteria, rifampin resistance
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The FDA today allowed marketing of the Xpert MTB/RIF Assay, an FDA-reviewed test able to detect tuberculosis bacteria and verify if the bacteria contain genetic markers that makes them rifampin-resistant.
According to the FDA release, the Xpert MTB/RIF Assay (Cepheid) is less complex to use than prior FDA-cleared tests for the detection of TB bacteria and is capable of providing results within approximately two hours, whereas traditional methods usually require one to three months.
Alberto Gutierrez
“Less complex tests such as the Xpert MTB/RIF Assay can be used in more diverse settings,” Alberto Gutierrez, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological said in a press release. “The early and rapid detection of rifampin-resistant TB can help curb the spread of drug-resistant TB, a major public health threat.”
The FDA assessed 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 significantly comparable to a legally-marketed device that is already available.
In support of the de novo petition, the manufacturer submitted data that included an evaluation of the assay’s accuracy in recognizing the TB bacteria as well as rifampin-resistant strains of the bacteria vs. validated test methods.
“New tools, including rapid and accurate diagnostic tests, are critical to advance the fight against TB,” Rear Admiral Kenneth G. Castro, MD, director of CDC’s Division of Tuberculosis Elimination said. “Early diagnosis and effective treatment for both drug-susceptible and drug-resistant cases are essential for improving patient health, preventing the spread of disease to others, and ultimately, achieving our goal of TB elimination in the US.”