GenePOC's Carba drug resistance assay clears FDA

2019 05 16 20 57 4949 Carbapenem Resistant Enterobacteriaceae 400

GenePOC's Carba test for detecting genetic sequences associated with carbapenemase-producing organisms resistant to treatment with antibiotics has been cleared by the U.S. Food and Drug Administration (FDA), the company announced on May 16.

The test was designed for use with the company's revogene system, a standalone unit with fluorescence-based real-time polymerase chain reaction (PCR) technology for testing in infectious disease settings. The assay detects and differentiates five common gene sequences associated with carbapenem nonsusceptibility -- blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP -- with results provided in about 70 minutes, according to the company. Clearance in the U.S. follows an announcement in April that the assay received the CE Mark.

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