Call: Clinical research for the validation of biomarkers and/or diagnostic medical devices

Responding to the challenge of an aging population, research and innovation (R&I) under Horizon 2020 is an investment in better health for all. It aims to keep older people active and independent for longer and supports the development of new, safer and more effective interventions. R&I under Horizon 2020 also contributes to the sustainability of health and care systems.

Leadership in enabling and industrial technologies (LEIT) includes the parts of Horizon 2020 focusing on new opportunities for industrial leadership in Key Enabling Technologies (KETs), ICT and space. These are areas of key industrial competences determining Europe’s global competitiveness. Aiming at new and breakthrough technologies, this part of the programme will contribute to boosting competitiveness, creating jobs and supporting growth. It will help to achieve the EU Industrial policy1 goals and represents an important component of the EU Strategy for Key Enabling Technologies.

Biomarkers are used in clinical practice to describe both normal and pathological conditions. They can also have a prognostic or a predictive power. They are therefore increasingly used in medicine and many potential biomarkers are proposed every year.

Only a few of them are however validated for use in a clinical research setting. Such validation implies the demonstration of a link to a pertinent clinical endpoint or process, as well as a robust and appropriate analytical method.

The clinical validation of biomarkers will be increasingly important for the development of new diagnostics, and this is a research area where many small European companies are active.

Improved clinical decisions should lead to better health outcomes while contributing to the sustainability of the health care system.