FDA Clears Test to Detect Bacteria Resistant to Carbapenem Antibiotics

The FDA has granted marketing approval to Cepheid’s Xpert Carba-R Assay, an infection control aid that tests patient specimens for specific genetic markers linked with bacteria that are resistant to Carbapenem antibiotics.

Carbapenem-resistant Enterobacteriaceae (CRE) can be found in almost all states in the United States.

“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, MD, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health within the Center for Devices and Radiological Health, in a press release.

Current methods of identifying resistant organisms involve long, drawn-out testing of antimicrobial susceptibility and bacterial culture examinations. The Xpert Carba-R Assay tests specimens directly from the patient, which speeds up the process.

However, the Xpert Carba-R Assay does not detect the bacteria, carbapenemase activity, or other possible nonenzymatic causes of carbapenem resistance. It only tests for genetic material.

The FDA’s decision to provide marketing clearance for Xpert Carba-R Assay is based on data from 2 clinical studies. In one, rectal swabs were taken from 755 patients in hospitals and long-term care facilities. The second trial involved 432 rectal swabs that were artificially prepared with specific concentrations of bacteria.

The researchers found that the Xpert Carba-R Assay and the traditional culture method led to similar results.