USDA Awards bioMérieux GENE-UP® Pathogenic E. coli (PEC) as Method of Choice for Shiga-Toxin Producing E. coli (STEC) Detection in USDA Food Safety and Inspection Service (USDA-FSIS) Laboratories

CHICAGO, IL – July 2, 2024 – bioMérieux, a world leader in the field of in vitro diagnostics, is pleased to announce 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 our current method. FSIS expects that industry will see reduced product holding times while waiting for laboratory results.

“We are delighted to receive this award from the USDA-FSIS,” said Miguel Villa, Sr. Vice President, Americas, Industrial Applications at bioMérieux. “With the addition of the GENE-UP^® PEC assay to the FSIS-methods of choice, bioMérieux continues to bring innovation to the market to ensure public health and food safety, playing our part to support food security and sustainability around the world.”

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. 

“Our Augmented Diagnostics approach was certainly leveraged for this exciting suite of innovations,” said John Shultz, Sr. Director, Sales and Marketing, Industrial Applications, at bioMérieux. “Harnessing our data and genomics expertise, we bring a unique offering to industries historically challenged with complex and oftentimes convoluted testing process for STECs. We are particularly excited about the inclusion of the GENE-UP^® PEC assay, which utilizes novel co-location of virulence genes to accurately detect pathogenic E. coli strains, dramatically reducing unnecessary food waste.”

A longtime diagnostic partner to the food industry, bioMérieux works closely with its customers to develop solutions that go beyond the test results, providing smarter, more dynamic solutions that provide actionable insights with unrivaled specificity to each production facility. Its complete portfolio of industry solutions supports the entirety of the production process, from pathogen detection, to quantification, to enumerating quality indicators and identification confirmation. 

For more information on GENE-UP^®, please visit https://www.biomerieux.com/corp/en/our-offer/industry-products/gene-up-automated-pathogen-detection.html

Pioneering Diagnostics

A world leader in the field of in vitro diagnostics since 1963, bioMérieux is present in 45 countries and serves more than 160 countries with the support of a large network of distributors. In 2023, revenues reached €3.7 billion, with over 90% of sales outside of France. 

bioMérieux provides diagnostic solutions (systems, reagents, software and services) which determine the source of disease and contamination to improve patient health and ensure consumer safety. Its products are mainly used for diagnosing infectious diseases. They are also used for detecting microorganisms in agri-food, pharmaceutical and cosmetic products.

www.biomerieux.com. 

bioMérieux is listed on the Euronext Paris stock market.
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