Oxford Nanopore announced CE‑IVDR and UKCA marking for its GridIon Dx sequencer, making it the company's first regulated IVD device in Europe and the UK and enabling clinical deployment in infectious‑disease and biopharma settings. The company flagged partnerships to commercialize assays on GridIon Dx (notably an AmPore‑TB test with BioMérieux) and forecasted ~22% revenue growth for 2025, with clinical revenue rising faster than research sales. The approval positions Oxford Nanopore to expand regulated sequencing into diagnostics and biomanufacturing markets, where medium‑throughput nanopore platforms could reduce time to actionable results for pathogen detection and clinical genomics.