bioMérieux Inc. GENE-UP NUTRAPLEX PRO assay awarded first-ever AOAC approval for multiplex USP pathogen detection and PCR-based culture confirmation in nutraceutical products
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 Methods approval (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.”