Cepheid, Sunnyvale, Calif, has received FDA premarket notification (510(k)) clearance for the Xpert Carba-R, a qualitative in vitro diagnostic test for identification of five distinct families of carbapenem resistance genes. The genes represent the most common carbapenemases identified globally, including IMP, KPC, OXA-48, NDM, and VIM.
Xpert Carba-R is the first FDA-cleared test for detection and differentiation of carbapenemase genes in pure bacterial isolates previously shown to be nonsusceptible to carbapenem antibiotics, which may be cultured from a wide range of clinical specimens, including blood cultures, urine, respiratory samples, abscesses, and swab surveillance specimens.
“The emergence of carbapenemase-producing organisms, known as CPOs, represents a significant global healthcare risk since these bacteria are resistant to many of the beta-lactam antibiotics used for empiric therapy for Gram-negative infections,” says David Persing, MD, PhD, chief medical and technology officer at Cepheid. “These resistance genes are highly transmissible from one bacterial species to another, leading to well-documented outbreaks associated with high morbidity and mortality.”
According to Persing, carbapenem resistance mechanisms may be difficult to characterize with conventional laboratory procedures. “Now, 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,” he says.
“The availability of a rapid and accurate molecular test for the most prevalent mechanisms of carbapenem resistance represents an important addition to the limited tools the laboratory has available to fight the emergence of multidrug resistant organisms, like CPOs,” says Paul Schreckenberger, PhD, director of microbiology at Loyola University Medical Center. “Knowing which carbapenemase gene is present in a resistant isolate helps the hospital identify and manage outbreaks and can also be valuable for monitoring the spread of multiresistant bacteria among hospital populations considered most at risk.”
Xpert Carba-R is the 20th US in vitro diagnostic test available to run on Cepheid’s GeneXpert system. For more information, visit Cepheid.