Applied BioCode secured expanded FDA 510(k) clearance for its BioCode Respiratory Pathogen Panel, adding automated extraction using Thermo Fisher Scientific’s KingFisher Flex platform. The cleared workflow pairs the RPP with Thermo automation and the company’s MDx-3000 automated detection system. Applied BioCode said the combined setup can detect 17 respiratory pathogens and is intended to help clinical labs optimize throughput and workflow while producing timely results. The company also noted it previously obtained expanded FDA clearance for its gastrointestinal pathogen panel using the same automation platform. This matters for the market’s push toward integrated sample-to-result automation, where regulatory clearance for specific extraction workflows can speed adoption across hospital and reference labs.
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