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As €7.5M European Can.Heal Project Wraps up, Participants Eye Ways to Implement Results

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NEW YORK – A European effort to support the integration of genomics in clinical cancer care and prevention will soon wrap up after producing a dozen reports that will inform both EU policies and national health strategies going forward.

The project, called Can.Heal, commenced in November 2022 with a budget of €7.5 million ($7.8 million), including €6 million from the EU, and will run through the end of April. It has 42 participants from 17 countries, including medical hospitals, universities, research and public health institutes, plus patient and stakeholder organizations.

Can.Heal set out to produce recommendations related to biobanking; polygenic risk scores and clinical decision tools; diagnostics, including decision support tools for molecular tumor boards; and clinical implementation of next-generation sequencing-based assays, including blood-based ones.

According to Els Van Valckenborgh, a scientist at Sciensano, Belgium's national public health institute, and a co-PI of Can.Heal, the value of the project lies in its "comprehensive approach to enhancing cancer prevention and care through innovative, evidence-based solutions." She added that the project will help to guide EU policy, as well as to establish ethical frameworks and support education and training such as e-learning programs designed for non-geneticist healthcare professionals.

"In essence, Can.Heal contributes to a future where personalized cancer care is more accessible, effective, and integrated into routine clinical practices across Europe, while fostering trust and ethical considerations in genomic medicine," she said.

The consortium's findings have already been made available in a series of publications that provide "strategic roadmaps" for policymakers, healthcare professionals, and industry, according to Denis Horgan, executive director of the European Alliance for Personalized Medicine, a Brussels-based organization that has led Can.Heal's policy and communication efforts.

The first, Precision Oncology: A Global Perspective on Implementation and Policy Development, offers strategies for integrating precision oncology into national healthcare systems, emphasizing the need for cross-sector collaboration and regulatory adaptation to support innovation. The second, From Theory to Practice: Implementing Next-Generation Sequencing and Public Health Genomics in Healthcare Systems, provides a roadmap for the adoption of genomic sequencing in routine care and underlines the importance of infrastructure development, workforce training, and equitable access.

Another report, Tackling the Implementation Gap for the Uptake of NGS and Advanced Molecular Diagnostics into Healthcare Systems, identifies obstacles to integrating molecular diagnostics into clinical practice, such as reimbursement challenges and data standardization, and stresses the need for stronger clinical utility evidence.

Accelerating the Development and Validation of Liquid Biopsy for Early Cancer Screening and Treatment Tailoring explores the role of liquid biopsy in cancer detection, monitoring, and treatment personalization, stressing the need for standards and regulatory as well as reimbursement hurdles.

Horgan said these publications "translate scientific advancements into actionable policies" that will "serve as essential tools for EU member states to accelerate the integration of personalized medicine into national healthcare systems."

A focus on genetic counseling and PRS

Matt McCrary, a researcher at the Institute of Human Genetics at Hannover Medical School in Germany, was an author on several Can.Heal papers focused on genetic counseling. He noted that health in Europe remains largely within the purview of national governments, but by creating shared policies, infrastructures, and approaches, Can.Heal's participants hope to streamline how care is implemented in the EU.

One paper he coauthored mapped the national and international legislation influencing genetic counseling in each member state, revealing a diversity of approaches and highlighting common challenges, such as genetic literacy, workforce capacity, and insurance reimbursement. Based on an extensive survey of geneticists, oncologists, and patient stakeholders, the paper delivered policy recommendations to the European Commission on how to best address these common barriers.

These included EU-wide recognition of genetic counselors, inclusion of genetics expertise in oncology guidelines, mandatory genetics education for oncologists, the creation of an EU registration and education system for genetic counselors, and mandatory reimbursement of genetic counseling when clinical guidelines are met.

Looking ahead, McCrary noted that these recommendations will be piloted in several EU-funded Joint Actions. One such effort is an EU-wide Joint Action on Personalized Cancer Medicine, announced last year, that will include implementation pilots related to liquid biopsies, polygenic risk scores, and molecular tumor boards. The effort has a preliminary total budget of €32 million, pending European Commission approval.

Another one is the Joint Action on the Prevention of Non-Communicable Diseases, which focuses on cancer and other non-communicable diseases and kicked off last year with a budget of €95 million.

Andres Metspalu, a professor of genomics and biobanking at the University of Tartu in Estonia, was a coauthor on several Can.Heal reports. In one, he and his colleagues assessed the portability of polygenic risk scores for cancer across different EU populations. Among its recommendations were the need for ancestry-matched PRS models, as scores performed differently depending on the population, and the need for more diverse genome-wide association studies. Given Europe's diverse population, scores might need to be weighted or adjusted for individuals of African or Asian descent, Metspalu said.

Another report reviewed the use of liquid biopsy for cancer detection and monitoring and examined challenges with clinical decision support systems, including the need for better integration into clinical workflows, data standardization, and trust in the recommendations provided by the systems.

The authors also reviewed the use of Oxford Nanopore's sequencing platform to analyze methylation patterns in cell-free tumor DNA obtained from patients whose polygenic risk scores showed a high likelihood of developing cancer. "Our analysis demonstrated the feasibility of this approach, and currently we are preparing to perform pilot experiments [at the University of Tartu] using real samples from patients and relevant controls," Metspalu said.

According to Horgan, the coming EU Joint Actions will serve as avenues for piloting Can.Heal's recommendations, adding that they will also guide EU investment strategies, particularly in biobanking, data integration, and workforce training.