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News From the Food and Drug Administration
August 16, 2016

Assay Detects Drug-Resistance Genes

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Copyright 2016 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.

JAMA. 2016;316(7):703. doi:10.1001/jama.2016.10684

The FDA has approved an assay to detect specific genetic markers indicating that bacteria are resistant to carbapenem antibiotics, which are widely used in hospitals to treat severe infections.

Methods currently used to identify drug-resistant organisms can take up to 4 days, and additional testing often is needed to confirm that carbapenemase, an enzyme that inactivates carbapenem antibiotics, is present. The Xpert Carba-R Assay can detect and differentiate among the most prevalent genetic markers of carbapenemase in about 48 minutes, according to the manufacturer, Cephid of Sunnyvale, California (

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