With drug-diagnostic co-development partnerships fueling advances in diagnostic testing for Alzheimer’s, Multiple Sclerosis, cardiovascular disease, rare genetic disorders, and cancer, 2025 is poised as a critical year for Europe’s precision medicine community. However, developing, clinically validating, regulatory filing and commercialising biomarkers and in vitro diagnostics remains no easy feat, as knowledge gaps persist in validating surrogate endpoints, co-developing scalable diagnostic testing workflows and infrastructure, navigating reimbursement pathways, and harmonising drug-diagnostic IVDR-adherence for approval in unmet patient need.