The Xpert Carba-R Assay diagnostic, which tests patient specimens for genetic markers associated with drug-resistant bacteria, has been approved by the U.S. Food and Drug Administration.
The test specifically looks for bacteria resistant to Carbapenem antibiotics, powerful drugs typically given in hospitals to treat severe infections. Standard methods require the organisms to be grown and tested in lab cultures, which can take four days or longer, the FDA said in a news release.
However, the agency stressed the new test only determines the presence of certain genetic markers, not for the actual resistant bacteria. It advised that hospitals should continue to use culture-based testing to confirm findings from the new test.
In two clinical studies involving more than 1,100 people, the new test was found to be as effective as culture-based testing in evaluating the presence of drug-resistant bacteria, the FDA said.
The Xpert Carba-Assay is produced by Cepheid, based in Sunnyvale, Calif.
Learn more about this approval from the FDA.
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