FDA permits marketing of Xpert MTB/RIF Assay for simultaneous detection of tuberculosis bacteria and resistance to the antibiotic rifampin. The test provides result in just two hours.
The U.S. Food and Drug Administration today allowed marketing of the Xpert MTB/RIF Assay. It is the first test reviewed by FDA that that can simultaneously detect TB bacteria and also could determine genetic markers that makes bacteriae resistant to rifampicin. Rifampicin is an important antibiotic for the treatment of TB.
The new test is less complex than previous tuberculosis detection tests. What matters most is the speed of the test results. The report on detection of TB bacteria and whether the bacteria are drug resistant, are available in approximately two hours.
Traditional methods to detect drug resistant tuberculosis usually require one to three months.
TB is a major worldwide health threat and is s caused by bacteria that belong to a group known as Mycobacterium tuberculosis complex. TB is a leading killer worldwide of people with HIV.
Most common site affected is lungs. Not everyone infected with M. tuberculosis develops active TB, and only people with active TB can spread the bacteria to other people.
Those with weakened immune systems are at a much higher risk for developing TB once infected with the bacteria, and TB can be fatal if left untreated.
“New tools, including rapid and accurate diagnostic tests, are critical to advance the fight against TB,” said RADM Kenneth G. Castro, M.D., director of CDC’s Division of Tuberculosis Elimination. “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 U.S.”
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 rifampin-resistant strains of the bacteria as compared to validated test methods.
The Xpert MTB/RIF Assay is manufactured and marketed by Cepheid of Sunnyvale, Calif.
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