Bringing an added level of confidence to the robust science that its assay offers, the bioMérieux, Inc. GENE-UP® NUTRAPLEX PRO™ multiplex pathogen detection assay has achieved the AOAC® Research Institute Performance Tested MethodsSMapproval (PTM 082103). AOAC validation demonstrated statistical equivalence to the U.S. Food and Drug (FDA) and U.S. Pharmacopeia (USP) reference methods for the detection of USP pathogens in comparative studies with a variety of nutraceutical matrices including nutrients, herbals and dietary supplements. GENE-UP® NUTRAPLEX PRO™ is the first-ever method to be validated as a multiplex pathogen screen and PCR culture confirmation method for USP pathogens in nutraceuticals.
“AOAC validation, demonstrating statistical equivalence to the FDA and USP reference methods, provides flexibility and confidence to nutraceutical companies,” said Adam Joelsson, director of R&D, Technology, bioMérieux, Inc., “ensuring a rapid, novel 24 hour multiplex pathogen detection and PCR culture confirmation solution in nutraceutical products.”
A real-time PCR solution for pathogen detection, GENE-UP NUTRAPLEX PRO simultaneously detects Escherichia coli, Salmonella spp. and Staphylococcus aureus from a single universal enrichment in just 24 hours.
“The AOAC approval of GENE-UP NUTRAPLEX PRO is a significant milestone in our ability to serve the nutraceutical industry,” said Ron Johnson, senior scientific affairs advisor at bioMérieux, Inc. and former president of the AOAC. “Providing validation against two globally recognized reference methods allows our customers – and the nutraceutical market-at-large – to maximize efficiency and flexibility without sacrificing data integrity and confidence in microbiological results.”
GENE-UP NUTRAPLEX PRO provides three key areas of value:
- Confident results backed with AOAC approval demonstrating FDA and USP reference method equivalence.
- PCR-based confirmation method equivalent to traditional culture confirmation.
- Operational efficiency and user simplicity, resulting in significant time and resource savings.
AOAC is a global standardization organization that certifies analytical test methods. The AOAC-RI Performance Tested MethodsSM 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 programs and explore its website to learn more about our suite of food safety and quality solutions.
A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux is present in 44 countries and serves more than 160 countries with the support of a large network of distributors. In 2020, revenues reached €3.1 billion, with over 93% 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.