FDA clears Xpert Carba-R assay to test patient specimens for CRE

The FDA has cleared Cepheid to market its Xpert Carba-R assay for the direct testing of patient specimens for carbapenem-resistant Enterobacteriaceae, or CRE.

The FDA already had approved the test in March to detect carbapenemase — an enzyme that inactivates carbapenem antibiotics — in pure bacterial isolates.

Now it can be used to analyze direct rectal swab specimens for specific genetic markers associated with CRE, delivering results in as little as 48 minutes, according to Cepheid. In comparison, traditional enriched culture methods typically take 3 to 5 days, the company said.

In a news release, Cepheid called the Xpert Carba-R “a valuable tool” in the fight against antimicrobial resistance. The FDA also highlighted the test’s ability to hasten the detection of CRE.

Alberto Gutierrez

“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,” Alberto Gutierrez, MD, director of the office of in vitro diagnostics and radiological health at the FDA’s Center for Devices and Radiological Health, said in a news release.

The Xpert Carba-R assay tests only for genetic material and is intended to be used in conjunction with other clinical and laboratory findings, the FDA said. According to the agency, the test does not detect the bacteria, carbapenemase activity or other possible nonenzymatic causes of carbapenem resistance. Because it does not detect all types of carbapenemase genes, labs using the Xpert Carba-R assay should continue to use bacterial cultures in conjunction with the test, the FDA said.

The FDA’s clearance was based on data from two clinical studies that showed the test performed similarly to the culture method.

Disclosure: Gutierrez reports no relevant financial disclosures.