Guardant Health received Japanese approval for its Guardant360 CDx as a companion diagnostic to identify ESR1 mutations and assess eligibility for Lilly’s Inluriyo in breast cancer patients. The Japanese clearance expands Guardant’s geographic footprint for tissue‑agnostic liquid biopsy testing tied to targeted therapies. Separately, Applied BioCode submitted an FDA claim to expand sample‑prep compatibility for its BioCode Respiratory Pathogen Panel to the Thermo Fisher KingFisher Flex system, aiming to shorten turnaround times and broaden lab adoption for its PCR‑based multiplex respiratory panel. Together, the moves reflect ongoing regulatory momentum for molecular diagnostics—both centralized liquid biopsies and multiplex PCR panels—affecting clinical trial enrollment, companion diagnostic strategy and lab workflows.