AOAC International Approves Predictive Assay

For the Detection of Pathogenic E. coli

March 21, 2022

bioMérieux obtains AOAC^® Performance Tested Methods^SM approval for a cutting-edge diagnostic to detect Pathogenic E. coli in food with GENE-UP^® PATHOGENIC E. COLI (PEC) Assay.

Chicago, Illinois — March 21, 2022 — bioMérieux, a world leader in the field of in vitro diagnostics, announces the approval of cutting-edge diagnostic assay for the detection of pathogenic E. coli. Escherichia coli (E. coli) is a bacterium that is commonly found in the human gastrointestinal tract. Some strains, however, can be pathogenic to humans. Shiga toxin-producing E. coli (STEC) are E. coli that produce shiga toxins encoded by stx genes, and are a significant public health risk. The U.S. Centers for Disease Control and Prevention estimates that 265,000 STEC infections occur each year in the United States.

Testing of food products for the presence of Shiga toxin-producing E. coli typically relies on detecting genes that encode Shiga toxin (stx), intimin (eae) and specific O-antigens. Until now, accurate detection of STEC organisms has presented significant challenges to the food safety industry, with low specificity and high false-positive rates.

bioMérieux now provides an exclusive solution for accurate detection of STEC in food thanks to GENE-UP PATHOGENIC E. COLI (PEC), a method evaluated and approved by the AOAC Performance Tested Methods^SM Program on February 23, 2022 and awarded certification number PTM 022203. The assay, developed in conjunction with researchers at the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), utilizes a novel co-localization gene target approach to provide never-before-seen accuracy and predictive results from a commercialized STEC diagnostic.

Dr. Vikrant Dutta, Senior Director, Scientific Affairs of Industrial Applications at bioMérieux says, “The timing of this approval matches both the FDA and USDA expectations for produce and beef industries to solve the ongoing issue of false positive results with STEC organisms, while providing unparalleled accuracy in detecting pathogenic STEC to protect our food supply and consumer health.”

“Such reductions in false positives could provide economic benefits to produce and beef processors alike”, says Dr. Stan Bailey, Senior Scientific Advisor of Industrial Applications at bioMérieux. “Accurate detection of pathogenic strains will bolster the safe-guards the industry and regulators have put in place.

Produce and beef producers can now take advantage of GENE-UP PEC and the entire suite of EHEC testing solutions from bioMérieux. This approval adds to a vast portfolio of international validations across the bioMérieux pathogen and quality indicator array of solutions, and demonstrates a long-standing commitment to robust, reliable, and validated science.

About bioMérieux

Pioneering Diagnostics

A world leader in the field of in vitro diagnostics for more than 55 years, bioMérieux is present in 44 countries and serves more than 160 countries with the support of a large network of distributors. In 2021, revenues reached €3.4 billion, with over 90% of international 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.

bioMérieux is listed on the Euronext Paris stock market
Symbol: BIM – ISIN Code: FR0013280286
Reuters: BIOX.PA/Bloomberg: BIM.FP

Corporate website: www.biomerieux.com.

About AOAC International

AOAC INTERNATIONAL is a global standardization organization that certifies analytical test methods. The AOAC Performance Tested Methods℠ designation is recognized by the US Department of Agriculture, the Food and Drug Administration, and global regulatory agencies. Visit AOAC’s website to learn more about their certification process and explore our website to learn more about our suite of food safety and quality solutions.