bioMérieux, Inc. GENE-UP® NUTRAPLEX PRO™ multiplex pathogen detection assay has attained the AOAC® Research Institute Performance Tested MethodsSM approval. AOAC validation showed the statistical equivalence of the U.S. Food and Drug (FDA) and U.S. Pharmacopeia (USP) reference methods for detecting USP pathogens in comparative studies with various nutraceutical matrices such as nutrients, dietary supplements, and herbals.
“AOAC validation, demonstrating statistical equivalence to the FDA and USP reference methods, provides flexibility and confidence to nutraceutical companies,” explained Adam Joelsson, director of R&D, Technology, bioMérieux, Inc. “This aspect ensures a rapid, novel 24-hour multiplex pathogen detection and PCR culture confirmation solution in nutraceutical products,” he added. A real-time PCR solution for pathogen detection, GENE-UP NUTRAPLEX PRO concurrently detects Escherichia coli, Salmonellas spp., and Staphylococcus aureus from a single universal enrichment in 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, he concluded.”
