The Precision Medicine Revolution has shifted to an evidence-based and ‘proactive’ rather than ‘reactive’ approach and, with this shift, has come the understanding that simply having viable treatments is no longer enough. Improved & earlier detection of disease and the continued identification of new biomarkers are vital steps in improving diagnosis, improving the safety and efficacy of existing medicines, and developing new medicines and targeted therapies. This, of course, highlights the need for innovative diagnostic solutions by small and dynamic companies. At the same time, emerging companies advancing novel, biomarker-based, technology-driven, or digital diagnostics face clear challenges when bringing solutions towards the market: funding is limited, partnering larger players holds potentially unforeseen expectations on how far the SME should have developed, and today’s standards for clinical trial design can act as a hinderance to this sector of the ecosystem. In this session, we aim to get at the root of biomarker and diagnostic-driven SME success, first by minimizing translation gaps between academia, pharma, and diagnostics, then by discussing critical steps in preparation, funding, & merging of strategies across sectors.