Funded under this topic are expected to:

• Set up a comprehensive interdisciplinary collaboration of the clinical research, industrial, public health, and health technologies communities to develop the screening platform and generate the evidence base for general population screening. This platform should be built to operate in an open-source environment allowing interoperability with applications from different providers, and build on clearly identified existing initiatives where relevant, while aiming at facilitating reusability (for example, a modular structure to enable flexibility and customisation to support new developments).
• Clinically validate and assess the utility of the screening platform and biomarkers to identify people at risk by designing and implementing a large-scale general population cohort screening study in several representative European countries.
• Design and clinically validate innovative assay technologies for disease risk identification, including digital technologies with data capture/analysis.
• Deliver digital tools for more effective and efficient management and execution of screening programmes and improved disease prevention. Artificial intelligence (AI) tools should be robust and explainable where relevant.
• Publish the relevant methods, standard operating procedures (SOPs), algorithms, standards and guidelines to allow the platform to be used more broadly and for diagnostics and therapies to be developed.
• Develop a plan/roadmap based on solid evidence to facilitate the regulatory qualification of the biomarkers identified and used within the project, and seek engagement with regulators where relevant (e.g. through the EMA Innovation Task Force, scientific advice).
• Develop and optimise relevant clinical practice guidelines through systematic evidence and outcome review, while addressing factors influencing uptake of these biomarkers in clinical practice.
• Raise awareness of disease prevention and provide training and education to relevant healthcare professionals, patients and family members.

A key objective is to facilitate changing healthcare practice, so applicants will need to demonstrate that their outputs can be taken up by healthcare systems and take steps to facilitate this.