Applied BioCode announced expanded FDA 510(k) clearance for its BioCode Respiratory Pathogen Panel, adding automated extraction using Thermo Fisher Scientific’s KingFisher Flex platform. The validated workflow pairs the RPP with automated sample preparation and BioCode’s MDx-3000 detection system for detecting 17 respiratory pathogens. The update aims to reduce manual steps for clinical laboratories and improve turnaround by integrating extraction automation into the cleared testing pathway. Applied BioCode said the company previously obtained expanded clearance for its gastrointestinal pathogen panel in combination with the same automation ecosystem. For hospital and reference lab operators, the key operational signal is compatibility with mainstream automation—an adoption lever that can speed deployment of multiplex respiratory testing during high-incidence seasons.
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