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Cepheid Carba-R 'Superbug' Test Gets Expanded Claims

NEW YORK (GenomeWeb) – Cepheid announced today that the Xpert Carba-R test has received clearance for expanded claims from the US Food and Drug Administration. The test can now be used on perirectal swabs and pure colonies.

Carba-R detects five families of resistance genes from carbapenemase-producing Gram-negative bacteria. It was CE marked in 2014 for use on rectal swabs, cleared by the US FDA for use with bacterial isolates following year, and granted an expanded US claim for rectal swabs in 2016. A study published that year suggested the assay might also be useful as a screening test.

Rapid detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48, and blaIMP gene sequences from pure colonies can help clinicians optimize patient management and direct therapeutic strategy, Cepheid noted in a statement. However, the firm added that the perirectal and rectal swab specimens are not intended to direct therapeutic strategy.

"The addition of perirectal swab specimens to the product label should facilitate active surveillance testing programs, while the ability to use Xpert Carba-R results for therapeutic strategies should enhance antimicrobial stewardship efforts, especially in hospitals struggling with the spread of multidrug-resistant organisms," Fred Tenover, Cepheid's vice president for scientific affairs, said in a statement.