ExpectedOutcome:

For an increasing number of cancers with underlying heritable genetic risk, early detection and diagnosis are possible. Moreover, cancer incidence and mortality across Europe are increasing and show substantial variation, with Central and Eastern European regions and countries particularly affected[1]. Decisive action on early detection using easy-to-use, specific and sensitive, affordable and accessible genetic multi-omics[2] or other biomarker-based tests[3] will contribute to diagnosing and treating cancer with an underlying heritable genetic risk at an earlier, potentially curable stage, and with fewer side-effects.

Proposals should aim to deliver results through validating, piloting, and upscaling genetic, multi-omics, or other biomarker-based tests for early detection of cancers with underlying heritable genetic risk in routine healthcare, which are directed and tailored towards and contribute to all of the following expected outcomes:

• People and their families at heritable genetic risk of developing cancer, will benefit from the outcomes of evidence-based, tailored, affordable and accessible early detection, based on accessible and affordable tests;
• Civil society, foundations, and innovators will seize opportunities to respectively co-create, support or commercialise early detection programmes based on genetic, multi-omics or other biomarker-based tests.
• Regional[4], and national policymakers and authorities in Member States and Associated Countries will engage in piloting, scaling up or implementing suitable early detection and treatment of people and their families with underlying heritable genetic risk in European regions based on genetic, multi-omics or other biomarker-based accessible and affordable tests, including legislative policies.

Scope:

There is a need to validate, pilot, and upscale easy-to-use genetic, multi-omics or other biomarker-based tests for early detection of cancers with an underlying heritable genetic risk, for uptake in regional or national healthcare systems. Proposals should address all of the following:

• Validate easy-to-use, affordable and accessible genetic, multi-omics or other biomarker-based cancer tests for early detection of cancers with an underlying heritable genetic risk for uptake in regional or national healthcare systems. Validation may include for example clinical studies, socio-economic or technological feasibility studies.
• Stratify the to-be-tested population by sex, gender, age or other determinants.
• Be compliant with GDPR and take into account socio-economic status, limited health literacy, limited awareness of disease symptoms and access for people in remote and rural areas[5].
• Tests can be based on, for example, polygenic cancer risk scores, algorithms, machine learning, biomarkers, cell lines, organoids, liquid biopsies, medical devices, or wearables and other digital applications.
• Co-create with end-users, including (citizens, and health professionals, such as psychologists) living in the targeted regions, aspects such as the innovation life cycle, priority definition, design, development, testing and piloting stages as well as risk assessment, counselling, health education, and acceptability.
• Extensively pilot and upscale genetic, multi-omics or other biomarker-based testing for use in early detection programmes in at least three regions across at least three different Member States or Associated Countries. One of the three targeted regions should be within the following Member States: Bulgaria, Croatia, Cyprus, Czech Republic, Estonia, Greece, Hungary, Latvia, Lithuania, Malta, Poland, Portugal, Romania, Slovakia or Slovenia.
• Preferably work together with one of the EIT-Health KIC networks[6] to establish appropriate contacts, and support relevant entrepreneurship, education, training, capacity building or innovation aspects for interested stakeholders in the targeted regions.

This topic requires the effective contribution of Social Sciences and Humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.

Successful results are expected to be communicated to the Knowledge Centre on Cancer (KCC)[7] to foster their uptake within the EU.

The Commission will facilitate coordination. Therefore, successful proposals will be asked to join the 'Prevention and Early Detection' cluster for the Mission on Cancer established in 2022[8] and should include a budget for networking, attendance at meetings, and potential joint activities without the prerequisite to give details of these at this stage. Examples are: organising joint workshops, establishing best practices, joint communication or citizen engagement activities with projects funded under other clusters and pillars of Horizon Europe, or other EU programmes, as appropriate. The details of joint activities will be defined during the grant agreement preparation phase and during the life of the project.

Specific Topic Conditions:

Activities are expected to achieve TRL 5 to 7 by the end of the project – see General Annex B.

[1]Cancer inequalities registry: https://cancer-inequalities.jrc.ec.europa.eu/

[2]Such as (epi)genomics, transcriptomics, proteomics, metabolomics, integrated omics.

[3]Test to detect cancer before the onset of disease. Tests to detect treatment resistance or relapse were the focus of the EIC Accelerator Challenge: Novel biomarker-based assays to guide personalised cancer treatment.

[4]Such as Managing authorities in regions: https://ec.europa.eu/regional_policy/in-your-country/managing-authorities_en; ERRIN - https://errin.eu/ and EUREGHA – https://www.euregha.net/ Background - Regions - Eurostat (europa.eu).

[5]For example, by considering mobile or digital healthcare services or working with a patient navigator.

[6]https://eithealth.eu/in-your-region/

[7]Hosted by the European Commission's Joint Research Centre (JRC). Especially through the ’European Guidelines and Quality Assurance Schemes for Breast, Colorectal and Cervical Cancer Screening and Diagnosis‘, and the 'European Cancer Information System (ECIS)’ and the 'European Cancer Inequalities Registry (ECIR)', see https://knowledge4policy.ec.europa.eu/cancer_en.

[8]In order to address the objectives of the Mission on Cancer, participants will collaborate in project clusters to leverage EU-funding, increase networking across sectors and disciplines, and establish a portfolio of Cancer Mission R&I and policy actions.