NEW YORK (GenomeWeb) – Quebec City-based GenePOC announced today that it has obtained clearance from the US Food and Drug Administration for a small molecular diagnostic panel test to detect carbapenem drug resistance.
The test is the fourth assay on the GenePOC Revogene system, and it detects five gene sequences in carbapenem-producing organisms (CPOs) that are most commonly associated with resistance.
Specifically, it detects the blaKPC, blaNDM, blaVIM, blaOXA-48-like, and blaIMP gene sequences associated with carbapenem non-susceptibility. The system performs the testing in up to eight samples per 70-minute run from CPO bacterial colonies.
"The FDA clearance for the GenePOC Carba assay represents a key milestone for GenePOC and shows how our technology is a key differentiator in the rapid diagnostics market" Patrice Allibert, CEO of GenePOC, said in a statement. "The flexibility of the technology will enable us to adapt to the constant evolution of this public threat by integrating more additional genes or subtypes as needed," he added.