FDA Approves New Test to Help Detect Drug-Resistant Bacteria

Share this content:
FDA Approves New Test to Help Detect Drug-Resistant Bacteria
FDA Approves New Test to Help Detect Drug-Resistant Bacteria

THURSDAY, June 30, 2016 (HealthDay News) -- 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 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.

More Information

Share this content:

is free, fast, and customized just for you!

Already a member?

Sign In Now »


Sign up for myCME e-newsletters


Drug Lookup

Browse drugs by: BrandGenericDisease

More in Home

Progress Made on Genetic Test for Anal Cancer

Progress Made on Genetic Test for Anal Cancer

But research is still in early stages

Four Separate Events Led to Zika's Introduction Into Florida

Four Separate Events Led to Zika's Introduction Into ...

Virus strains came from the Caribbean and Latin America, researchers say

New Health Care Act Could Result in 23 Million Losing Insurance

New Health Care Act Could Result in 23 ...

While premiums may lower over the long-term, many would face much higher out-of-pocket costs

is free, fast, and customized just for you!

Already a member?

Sign In Now »