FDA clears first test to detect specific genetic markers for certain antibiotic-resistant bacteria directly from clinical specimens

"U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Wed, 29 Jun 2016 16:48:18 -0500

Title:     FDA clears first test to detect specific genetic markers for certain antibiotic-resistant bacteria directly from clinical specimens

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FDA clears first test to detect specific genetic markers for certain antibiotic-resistant bacteria directly from clinical specimens
06/29/2016 04:57 PM EDT

The U.S. Food and Drug Administration today cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests patient specimens to detect specific genetic markers associated with bacteria that are resistant to Carbapenem antibiotics. Carbapenem antibiotics are widely used in hospitals to treat severe infections. These resistant organisms are commonly referred to as Carbapenem-resistant Enterobacteriaceae, or CRE, and have been reported in almost all states within the U.S.

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