Applied BioCode expanded the usability of its BioCode Respiratory Pathogen Panel (RPP) after receiving expanded FDA 510(k) clearance to pair the assay with Thermo Fisher Scientific’s KingFisher Flex automated extraction. The cleared workflow combines the RPP run on BioCode’s MDx-3000 automated detection system with KingFisher Flex sample processing. Applied BioCode said the integration enables labs to automate extraction and detection while targeting 17 prevalent respiratory pathogens in a single panel. The company previously secured expanded clearance for a Gastrointestinal Pathogen Panel (GPP) paired with the same Thermo system. For clinical laboratories, expanded interoperability can reduce manual handling steps and improve throughput, which becomes especially relevant in high-demand respiratory season periods. Separately, Veristat is buying Certara’s regulatory and medical writing services unit for up to $135 million, adding 200+ specialists and aiming to deepen submission and regulatory writing capabilities. Veristat expects the acquisition to accelerate its involvement in future approvals without changing project delivery timelines. Together, the news points to two complementary pressures in diagnostics and services: operational automation for assay execution and consolidation of regulatory expertise to manage increased submission complexity.
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