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GenePOC Carbapenem Resistance MDx Panel Gets FDA Clearance

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.

Meridian Bioscience announced earlier this month plans to acquire GenePOC for up to $120 million, with the expectation that it will rejuvenate their molecular diagnostics business.