Realising the promise of precision cancer diagnostics

Realising the promise of precision cancer diagnostics: Towards a European strategy for overcoming implementation barriers to enhance patient outcomes and European competitiveness

Background:

Precision cancer medicine (PCM) relies on advanced diagnostics such as next-generation sequencing (NGS) and liquid biopsy to guide diagnosis and treatment. Implementation of precision cancer diagnostics in Europe is uneven, with uptake of multi-biomarker NGS testing ranging from 0% to >50% (PMID: 36194905).

While NGS is actively promoted within European Society for Medical Oncology (ESMO) recommendations (PMID: 38834388), adoption is hindered by limited financial resources and qualified personnel and complicated by legal and technical considerations. Systemic investment and reimbursement mechanisms require buy-in from health authorities without which NGS uptake will remain fragmented, slow, and inequitable across Europe.

The slow uptake restricts access to approved therapies, particularly for rare cancers (PMID: 40436909) and also limits recruitment to clinical trials (PMID: 38698538). We argue that slow NGS adoption undermines the progress of biotechnology innovation in the European Union (EU). (Draghi M. The Future of European Competitiveness. European Commission; 2024).

Methods:

This paper examines barriers to implementation of precision diagnostics in Europe across financial, organisational, competency, data management, and regulatory domains (PMID: 39847746). It reviews ongoing EU joint actions, European Network for Comprehensive Cancer Centres (EUnetCCC), Joint Action on Networks of Expertise in Cancer (JANE-2), and Joint Action on Precision Cancer Medicine (JA-PCM) launched to address Europe’s Beating Cancer Plan (EBCP). Our analysis integrates evidence from literature, policy reports, and stakeholder perspectives to propose actionable strategies.

Results:

Key barriers to successful implementation of precision cancer diagnostics include high implementation costs, fragmented pathways for regulatory and reimbursement pathways, and gaps in education among others (PMID: 40394190). EUnetCCC, JANE-2, and JA-PCM aim to address these challenges through several actions including reimbursement pathway mapping, best practice guidelines for stakeholder roles, certified training for healthcare professionals, and harmonised data collection protocols.

Pilots related to Liquid biopsy and external quality assurance schemes ensure compliance with regulatory standards, enhancing diagnostic access and quality.

Conclusions:

By harmonising implementation strategies, data collection, and decision-making, EU joint actions can address barriers to the adoption of precision diagnostics, ensuring rapid uptake and equitable access across EU Member States and associated countries including Norway, Ukraine, and Moldova. These efforts will improve patient outcomes, particularly for rare cancers, boost enrolment in clinical trials. Further, a streamlined European approach would

foster a dynamic biotech ecosystem, as emphasized in the Draghi report (2024). Establishing clear pathways for biomarker-based approvals and tumour-agnostic strategies (PMID: 40609582) will position the EU as a global leader in precision oncology, attracting investment and clinical trials.

Authors: EUnetCCC, JANE-2 and JAPCM