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GenePOC Receives CE Mark for Drug-Resistant Bacteria Test

NEW YORK (GenomeWeb) – GenePOC announced today the CE marking of its Carba assay for carbapenemase-producing organisms, a class of bacteria resistant to carbapenem antibiotics.

The PCR-based in vitro diagnostic is designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences, which are associated with carbapenem resistance. It can provide results for up to eight sample in approximately 70 minutes and runs on the Canadian firm's Revogene automated instrument.

"A test [that] offers rapid and accurate results will contribute to the identification of colonized patients, therefore limit the spread of these organisms in healthcare settings and save on hospital costs," GenePOC CEO Patrice Allibert said in a statement. "Our GenePOC Carba assay also demonstrates the power of our technology to be compatible with panel detection."

Earlier this year, GenePOC received US Food and Drug Administration clearance for its group A Streptococcus test. The Revogene system won FDA clearance in mid-2017.