GENE-UP® PEC is a real-time
PCR-based AOAC validated solution for the meat, produce, and food
safety industry
CHICAGO, July 2, 2024
/PRNewswire/ -- 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.
GENE-UP® PEC is the latest bioMérieux
molecular diagnostic solution to be recognized by US food safety
regulatory bodies
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, product
hold times and 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/us/en/our-offer/industry-products/gene-up-pathogenic-e-coli-pathogen-detection.html
ABOUT BIOMÉRIEUX
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.
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