FDA Clears GenePOC Carba Assay

FDA has cleared a GenePOC 510(k) for the Carba assay and its use with the Revogene device to detect carbapenem-producing organisms (CPO). CPOs are known to be resistant to commonly used antibiotics and occasionally completely resistant to all available antibiotics, the compamy says.

The qualitative, in vitro diagnostic test is designed for the detection and differentiation of the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem-non-susceptibility, according to GenePOC. It says the assay can provide results for one to eight samples in about an hour using characterized carbapenem-non-susceptible pure colonies of Enterobacteriaceae, Acinetobacter baumannii, or Pseudomonas aeruginosa.

Revogene is an automated and stand-alone device, the company says, enabling testing of single-use proprietary microfluidic cartridges with fluorescence-based real-time polymerase chain reaction technology to deliver a diagnosis.