Bringing Onco-innovation to Europe's Healthcare Systems: The Potential of Biomarker Testing, Real World Evidence, Tumour Agnostic Therapies to Empower Personalised Medicine

Denis Horgan; Gennaro Ciliberto; Pierfranco Conte; Giuseppe Curigliano; Luis Seijo; Luis M. Montuenga; Marina Garassino; Frederique Penault-Llorca; Fabrizia Galli; Isabelle Ray-Coquard; Denis Querleu; Peter Riegman; Keith Kerr; Hendrik Van Poppel; Anders Bjartell; Giovanni Codacci-Pisanelli; Benedikt Westphalen; Jasmina Koeva-Balabanova; Angelo Paradiso; Zorana Maravic; Vassiliki Fotaki; Nuria Malats; Chiara Bernini; Simonetta Buglioni; Alastair Kent; Elisabetta Munzone; Ivica Belina; Jan Van Meerbeeck; Michael Duffy; Beata Jagielska; Ettore Capoluongo

Working Paper Article Version 1 This version is not peer-reviewed

Version 1 : Received: 17 August 2020 / Approved: 18 August 2020 / Online: 18 August 2020 (16:30:04 CEST)

Rapid and continuing advances in biomarker testing are not being matched by uptake in health systems, and this is hampering both patient care and innovation. It also risks costing health systems the opportunity to make their services more efficient and, over time, more economical. The potential that genomics has brought to biomarker testing in diagnosis, prediction and research is being realised, pre-eminently in many cancers, but also in an ever-wider range of conditions – notably BRCA1/2 testing in ovarian, breast, pancreatic and prostate cancers. Nevertheless, the implementation of genetic testing in clinical routine setting is still challenging. Development is impeded by country-related heterogeneity, data deficiencies, and lack of policy alignment on standards, approval – and the role of real-world evidence in the process - and reimbursement. The acute nature of the problem is compellingly illustrated by the particular challenges facing the development and use of tumour agnostic therapies, where the gaps in preparedness for taking advantage of this innovative approach to cancer therapy are sharply exposed. Europe should already have in place a guarantee of universal access to a minimum suite of biomarker tests and should be planning for an optimum testing scenario with a wider range of biomarker tests integrated into a more sophisticated health system articulated around personalised medicine. Improving healthcare and winning advantages for Europe's industrial competitiveness and innovation require an appropriate policy framework – starting with an update to outdated recommendations.

cancer biomarkers; BRCA1/2; genomics; European recommendation

Medicine and Pharmacology, Oncology and Oncogenics

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Bringing Onco-innovation to Europe's Healthcare Systems: The Potential of Biomarker Testing, Real World Evidence, Tumour Agnostic Therapies to Empower Personalised Medicine

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