Tag Archives: GenePOC

June 2019—GenePOC announced that its GenePOC Carba assay received CE marking. The assay is a qualitative, in vitro diagnostic test designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem nonsusceptibility.

April 2019—GenePOC announced its GenePOC Strep A assay has been cleared by the FDA for use with the Revogene device. The assay is a qualitative in vitro diagnostic test for the detection of Streptococcus pyogenes nucleic acids from throat swab specimens. It can provide results in 42 minutes for positive specimens and in about 70 minutes for negative specimens, without the need for culture confirmation.