Molecular Test for Rapid and Accurate Detection of Carbapenemase-producing Gram-negative Bacteria released in Europe

Cepheid has announced the release of Xpert® Carba-R, an on-demand molecular test for rapid and accurate detection of carbapenemase-producing Gram-negative bacteria, to be marketed as a CE IVD product under the European Directive on In Vitro Diagnostic Medical Devices. The test runs on Cepheid’s GeneXpert® System, the world’s leading molecular diagnostic platform. Xpert Carba-R detects and differentiates genes encoding the most prevalent carbapenemases, reporting five gene families that comprise 68 known individual resistance genes, including KPC, NDM, VIM, OXA-48 and IMP-1.

“Carbapenemase-producing organisms were named for their ability to fight off carbapenem antibiotics, the last line of defence in our medical toolbox,” said John Bishop, Cepheid's Chairman and CEO. “Xpert Carba-R provides healthcare institutions a much needed tool for rapid and accurate detection of patients colonised with these multidrug resistant organisms to help prevent widespread outbreaks and determine the best infection prevention pathways.”

“Detection of patients carrying carbapenemase-producing microorganisms, with differentiation among the five major families of resistance genes, can significantly impact infection control. With results in less than an hour, we have the advantage of rapid implementation of epidemiological measures to control the spread of these microorganisms,” said Dr Rafael Cantón, Professor of Microbiology at the Hospital Universitario Ramón y Cajal, Madrid, Spain.

Carbapenemases of global importance include Klebsiella pneumonia carbapenemase (KPC), New Delhi metallo-β-lactamase (NDM), Verona integron-encoded metallo-β-lactamase (VIM), imipenemase metallo-β-lactamase (IMP), and oxacillinase-48 (OXA-48). As of 2014, KPC is the most widespread carbapenemase in the United States while OXA-48 is becoming the most important one in most European countries.

“Like our other GeneXpert cartridges, Xpert Carba-R can be performed on a STAT basis — no waiting for batched results. Rapid identification of colonised patients allows healthcare institutions to begin immediate implementation of infection control measures to prevent spread in highly susceptible populations,” said David Persing, MD, PhD, Cepheid's Chief Medical and Technology Officer. “Active screening of high risk patients has the additional benefit of allowing clinicians to optimise isolation decisions and avoid the impact of unnecessary isolations.”