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Cepheid's Carba-R Assay Gets Expanded FDA Approval

NEW YORK (GenomeWeb) ­– Cepheid announced today it has received clearance for an expanded claim on its Xpert Carba-R test for use directly from rectal swab specimens.

The US Food and Drug Administration cleared the test in March for detection and differentiation of carbapenemase genes in bacterial isolates.

The new claim positions the Carba-R test for use as a tool to identify patients colonized with carbapenem-resistant organisms (CPOs), and an international study published earlier this year suggested the test could have utility for that type of screening application. 

The test is the first on-demand real-time PCR test for CPOs. It delivers results in about 50 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," David Persing, Cepheid's chief medical and technology officer, said in a statement.

Xpert Carba-R will begin shipping in July, and is part of a portfolio of tests for antimicrobial-resistant infections that includes assays for methicillin-resistant Staphylococcus aureus, Clostridium difficile, vancomycin-resistant enterococci (VRE), and rifampin-resistant tuberculosis.