NEW YORK (GenomeWeb) – GenePOC announced today that its rapid molecular assay to detect group A Streptococcus has been granted clearance by the US Food and Drug Administration.
The test, which runs on GenePOC's Revogene instrument, is the third test from the Quebec City-based diagnostics developer to be FDA cleared. It uses throat swab samples and can report positive Strep A results in as little as 42 minutes, and negative results in 70 minutes without requirement for confirmation by bacterial culture, the firm said in a statement.
The company obtained FDA clearance of its Revogene instrument and an assay for group B Strep in 2017, followed by an assay to detect Clostridium difficile. GenePOC is also currently developing small molecular panels for carbapenem-resistant enterobacteriaceae (CRE) and gastrointestinal infections.
"GenePOC is committed to developing important assays to complete its current offering, becoming a strong player in the field of rapid molecular diagnostics," CEO Patrice Allibert said.