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Cancer Biomarkers are the key to unlocking the promise of precision oncology, selecting which patients will respond to a more personalised treatment while sparing non-responders the therapy-related toxicity. In this paper, we highlight the primacy of cancer biomarkers, but focus on their importance to patients and to health systems. We also highlight how cancer biomarkers represent value for money. We emphasise the need for cancer biomarkers infrastructure to be embedded into European health systems. We also highlight the need to deploy multiple biomarker testing to deliver the optimal benefit for patients and health systems and consider cancer biomarkers from the perspective of cost, value and regulation. Cancer biomarkers must also be situated in the context of the upcoming In Vitro Diagnostics Regulation, which may pose certain challenges (e.g. non-compliance of laboratory developed tests, leading to cancer biomarker shortages and increased costs) that need to be overcome. Cancer biomarkers must be embedded in the real world of oncology delivery and testing must be implemented across Europe, with the intended aim of narrowing, not widening the inequity gap for patients. Cancer patients must be placed firmly at the centre of a cancer biomarker informed precision oncology care agenda.

Taking real advantage of Europe’s excellence to improve citizens’ lives presents challenges that Europe’s policymakers have not yet fully met. The European Union and Member States have shown some clarity of assessment in recognising the needs, and some laudable determination to improve the situation, and it has intermittently taken some real steps to deliver on its ambitions to turn its excellence into valuable innovations for the benefit of citizens. But as we move towards the third decade of the 21st century, Europe still faces some harsh choices about whether it is actually going to do what it has so often discussed to allow the EU to be a center for health innovation. The EU has to make some firm decisions about what deserves support - and where. It must turn words into deeds about promoting effective links between investment that will facilitate inward investment to the EU. That requires a sharper focus about developing and retaining the right skill sets in Europe, about funding innovation, about creating an encouraging regulatory environment, and about building greater public understanding and engagement. The framework document represents a mission oriented approach to integrating personalised medicine and personalised healthcare in Europe.

In respect of Personalised Medicine, Big Data represents the vast and continuously growing amount of health information (including biomedical and environmental) and its usage to drive innovation in translational research and health outcomes tailored to the individual. Using these data to first understand the cause of disease, the medical profession can then develop new drugs and therapies to find the cure, as well as other health interventions targeting the individual. The personalised, individual approach requires advanced technologies and processes to collect, manage and analyse the information and, even more importantly, to contextualise it, integrate it, interpret it and provide rapid and precise decision support in a clinical and public health context.