Applied diagnostics automation expands FDA-cleared testing workflows

Applied BioCode received expanded FDA 510(k) clearance for its multiplex respiratory pathogen panel, adding an automated extraction workflow using Thermo Fisher Scientific’s KingFisher Flex platform. The cleared workflow pairs the BioCode MDx-3000 with KingFisher Flex extraction, enabling lab teams to detect 17 respiratory pathogens while optimizing throughput and reducing manual steps.