“Validated. Scalable. Still out of reach.”
Breakthroughs in oncology diagnostics, such as circulating tumour DNA (ctDNA), liquid biopsy, and AI-enhanced pathology, have matured to the point of clinical validation. Their potential to transform patient outcomes through earlier detection, recurrence monitoring, and stratified treatment decisions is beyond dispute. However, widespread implementation remains elusive. Less than 20% of eligible patients across high-income European countries benefit from these innovations, reflecting a structural failure in the policy and delivery ecosystem.
This session will critically examine the systemic bottlenecks that delay the adoption of precision diagnostics. These include fragmented and inconsistent reimbursement frameworks across Member States, misalignment between regulatory pathways and the speed of innovation, and a lack of coordinated EU-level procurement mechanisms for diagnostic technologies. While pilot programmes in countries like Germany and the Netherlands have demonstrated the feasibility of integrating ctDNA testing and AI-assisted pathology into oncology care, these remain the exception rather than the rule.
Drawing on the policy priorities of EU4Health, the European Health Data Space (EHDS), and the ongoing implementation of the HTA Regulation, the discussion will present concrete policy pathways to scale diagnostic innovation. Key topics will include joint EU–national regulatory frameworks, value-based pricing models for diagnostics, embedding AI into standard pathology workflows, and the role of cross-border molecular diagnostics in ensuring equitable access.
EAPM has long advocated for the systemic integration of innovation-readiness into national cancer control plans, including readiness assessments, interoperable data infrastructures, and public-private models for diagnostic procurement. This session aligns with the broader aim of moving beyond fragmented pilot projects to a harmonised European approach that supports timely, equitable, and scalable adoption of advanced diagnostics.
Conclusion:Closing the implementation gap in cancer diagnostics is no longer a matter of evidence generation but of governance, alignment, and systemic reform. Europe's cancer systems must be reconfigured to deliver precision tools not only with scientific excellence, but with equity, efficiency, and urgency.
