FDA approves Xpert Carba-R Assay diagnostic for Carbapenem-resistant Enterobacteriaceae infection- Cepheid

The FDA cleared for marketing the Xpert Carba-R Assay, from Cepheid, 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.

The FDA�s decision to provide clearance was based on data from two clinical studies. A prospective study used rectal swabs from 755 patients in hospitals or long-term care facilities to compare results from the Xpert Carba-R Assay with results from reference cultures and automated real-time polymerase chain reaction (PCR) sequencing. A second study designed to test the clinical performance of the Xpert Carba-R Assay used 432 rectal swabs that were artificially prepared with specific concentrations of bacteria containing the genes detected by the test. The results of these studies demonstrated similar performance between the Xpert Carba-R Assay and culture method.

Comment: The Xpert Carba-R Assay tests specimens directly taken from patients, which are usually obtained by rectal swabs, for the presence of five different genetic markers that are associated with carbapenemase, the enzyme produced by CRE.