FDA approves new test to help detect drug-resistant bacteria

FDA approves new test to help detect drug-resistant bacteria

(HealthDay)—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. 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 individuals, the new was found to be as effective as culture-based testing in evaluating the presence of drug-resistant , the FDA said.

The Xpert Carba-Assay is produced by Cepheid, based in Sunnyvale, Calif.


Explore further

Automated Ebola blood test performs well in field evaluation

More information: More Information

Health News Copyright © 2016 HealthDay. All rights reserved.

Citation: FDA approves new test to help detect drug-resistant bacteria (2016, July 1) retrieved 15 July 2019 from https://medicalxpress.com/news/2016-07-fda-drug-resistant-bacteria.html
This document is subject to copyright. Apart from any fair dealing for the purpose of private study or research, no part may be reproduced without the written permission. The content is provided for information purposes only.
0 shares

Feedback to editors

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more