USDA-FSIS Selects bioMérieux GENE-UP® Pathogenic E. coli Assay as Detection Method of Choice

After an evaluation of commercially available pathogen screening technologies, bioMérieux's GENE-UP® Pathogenic Escherichia coli assay (PEC) has been selected by the U.S. Department of Agriculture’s Food Safety and Inspection Service’s (USDA’s FSIS’) Field Service Laboratories as the primary method for Shiga toxin-producing E. coli (STEC) detection.

FSIS will use the bioMérieux GENE-UP® PEC platform to screen enriched samples received on or after September 16, 2024 for the adulterant STEC. The screening method adds efficiency by employing a novel molecular diagnostic target to rapidly identify samples containing STEC. 

FSIS expects that adoption of this new screening method will reduce the number of potential and presumptive positive STEC results that do not confirm positive with bioMérieux’s current method. The agency also expects that industry will see reduced product holding times while waiting for laboratory results.

GENE-UP® PEC is the latest of bioMérieux's molecular diagnostic solutions to be recognized by food safety regulatory bodies in the U.S., and pairs with a suite of diagnostic solutions that detect pathogenic E. coli via eae/stx genes, O serogroups, and novel co-location of virulence genes, enabling improved presumptive and confirmation analysis of potential positive samples.