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FDA Clears Cepheid Xpert Carba-R Test on GeneXpert System

NEW YORK (GenomeWeb) – The US Food and Drug Administration has granted Cepheid clearance to market the Xpert Carba-R test, the firm announced today.

According to the company, it is the first FDA-cleared test to detect and differentiate carbapenemase genes in pure bacterial isolates that were previously determined to be non-responsive to carbapenem antibiotics, considered the last line of defense to treat infections. The test identifies 5 families of carbapenem resistance genes in carbapenem-producing organisms (CPOs), including KPC, NDM, VIM, OXA-48, and IMP.

Xpert Carba-R runs on the Cepheid GeneXpert system—the company recently said that it has placed 10,000 systems globally as of this week. 

"These resistance genes are highly transmissible from one bacterial species to another, leading to well-documented outbreaks associated with high morbidity and mortality," noted David Persing, Cepheid's chief medical and technology officer, in a statement. "With a bacterial isolate and less than a minute of hands-on time, Xpert Carba-R delivers a result in under an hour, allowing timely detection and differentiation of the most prevalent carbapenemase genes associated with CPO outbreaks to support infection control efforts."

The test is the 20th US-IVD assay on the Xpert menu, the firm noted, including a suite of hospital-acquired infection-related assays such as ones for multi-drug resistant Staphylococcus aureus, Clostridium difficile, and vancomycin-resistant Enterococci.

Cepheid also noted the US Centers for Disease Control and Prevention's newly published study characterizing carbapenem-resistant Enterobacteriaceae as an "urgent threat." Other experts have also recently pointed out the need to carefully validate any molecular CRE assays that may potentially be used to directly test patient samples, as opposed to bacterial cultures, for screening purposes. 

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