FDA Supports Expanded Claims for Xpert Carba-R Test for "Superbugs"

Cepheid has announced that it has received clearance from the U.S. Food and Drug Administration (FDA) for expanded claims for Xpert® Carba-R, the first FDA-cleared test for detection of carbapenem resistance genes of multidrug resistant 'superbugs'. Following initial clearance in March for detection and differentiation of carbapenemase genes in pure bacterial isolates, the latest clearance extends use of the assay to the analysis of direct rectal swab specimens, and positions Xpert Carba-R as a valuable tool for the identification of colonized patients and as an aid to infection control efforts, both of which Cepheid believes are needed to escalate the fight against antimicrobial resistance.

"The number of global incidents associated with these deadly bacteria is surging, and is frequently associated with high morbidity and mortality, in addition to increased hospital costs1," said David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "Xpert Carba-R delivers a highly accurate result in as little as 48 minutes, enabling clinicians to assess high-risk patients for colonization status at or prior to admission, to enact full preventative measures as necessary to reduce the risk to the patient, the broader patient population, and hospital staff. In contrast, traditional enriched culture methods typically take 3-5 days."

The CDC recommends comprehensive infection control measures for patients who are colonized or infected with carbapenemase-producing organisms2, known as CPOs or 'superbugs'. CPOs are often resistant to many of the beta-lactam antibiotics used for empiric therapy for gram-negative infections, in addition to other classes of antibiotics.

"Surveillance is a key infection prevention activity for monitoring and controlling the spread of CPOs in hospitals and long term care facilities," said Lance Peterson, M.D., Director of Microbiology and Infectious Diseases Research, NorthShore University Health System. "Xpert Carba-R is the first real time PCR test for CPOs in the United States that can be performed on demand, thus facilitating surveillance studies."

Xpert Carba-R adds to the portfolio of Xpert tests offered by Cepheid to help infection control professionals fight antimicrobial resistance including MRSA, C. difficile, VRE, and MTB-RIF. Xpert Carba-R runs on Cepheid's GeneXpert System, the world's leading molecular diagnostic platform with more than 10,000 systems installed globally. Xpert Carba-R with the extended claim will begin shipping in July.