bioMérieux announced that the company's GENE-UP Pathogenic E. coli (PEC) assay has been selected by the USDA-FSIS Field Service Laboratories as the primary method for Shiga toxin-producing E. coli detection. According to the June 28, 2024 USDA Constituent Update, FSIS evaluated commercially available pathogen screening technologies and will adopt a new rapid screening test for adulterant Shiga toxin-producing E. coli (STEC). Specifically, FSIS will use the bioMérieux GENE-UP Pathogenic E. coli (PEC) platform to screen enriched samples received on or after September 16, 2024, for adulterant STEC.

This 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 the company's current method. FSIS 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 United States, 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 allowing for improved presumptive and confirmation analysis of potential positive samples. Recently, the USDA also awarded bioMérieux the contract for GENE-UP CAMPYLOBACTER as the FSIS method of choice. Earlier this year, bioMérieux announced a research collaboration to improve microbial detection of food-borne pathogens with the Food and Drug Administration, and in 2022, the USDA named bioMérieux's GENE-UP QUANT Salmonella quantification method of choice in all FSIS laboratories.

Now, with GENE-UP, TEMPO, and VITEK solutions currently included in the USDA Microbiology Laboratory Guidebook (MLG), bioMérieux holds the most USDA-FSIS methods of choice for microbiology than any other diagnostics provider.