Posted by Michael Wonder on 29 Jun 2016
FDA clears first test to detect specific genetic markers for certain antibiotic-resistant bacteria directly from clinical specimens
29 June 2016 - The U.S. FDA 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.
“By using a specimen taken directly from a patient to test for the presence of genetic markers, hospitals can more quickly identify these dangerous bacteria resistant to certain antibiotics,” said Alberto Gutierrez, M.D., director of the FDA’s Office of In Vitro Diagnostics and Radiological Health within the Center for Devices and Radiological Health.
