LB-ctDNA: Implementation of ctDNA guided decision-making across the patient journey (LB-ctDNA)

This pilot will assess the use of blood-based tests to detect, monitor, or follow cancer in a less invasive way. The pilot supports the use of liquid biopsy (LB) technologies at multiple points in the cancer care continuum, from early detection and diagnosis to monitoring and follow-up. The overall goal is to create a Europe-wide system that improves diagnostic accuracy, supports better treatment decisions, and helps inform reimbursement based on health technology assessments (HTA).

It promotes equity in implementation by involving countries with differing levels of readiness, supported by quality assurance tools. It will be a pragmatic, learn-by-doing pilot to allow countries with less mature liquid biopsy infrastructure and capabilities to learn from those leading this development in a co-creational pilot. Participating centres will use shared data standards, follow established liquid biopsy guidelines, and take part in quality checks and training programmes. The pilot will also work on building scalable testing systems for circulating tumour DNA (ctDNA) that meet EU regulatory requirements (IVDR). It will involve collaboration with European expert networks to strengthen quality and consistency.