Bringing onco-innovation to Europe’s healthcare systems: the unexploited potential of biomarker testing, real world evidence and the potential of Tumour Agnostics. The lesson from BRCA1/2 genetic testing

Denis Horgan; Gennaro CILIBERTO; Pierfranco Conte; Giuseppe CURIGLIANO; Luis Seijo; Luis M. Montuenga; Luis Paz-Ares; Marina Chiara Garassino; Penault-Llorca Frederique; Fabrizia GALLI; Isabelle Ray-Coquard; Denis Querleu; David R. Baldwin; Susana Banerjee; Peter H.J. Riegman; Keith Kerr; Benjamin Horbach; Reinhard Büttner; Hendrik Van Poppel; Anders Bjartell; Giovanni Codacci-Pisanelli; Westphalen Christoph Benedikt; Fabien CALVO; Jasmina Koeva-Balabanova; Stephen Hall; Angelo Virgilio Paradiso; Dipak. Kalra; Christa M. Cobbaert; Rocio Varea Mendez; Zorana Maravic; Vassiliki Fotaki; Jaafar Bennouna; Estelle Cauchin; Núria Malats; Iñaki Gutiérrez-Ibarluzea; Benjamin Gannon; Ken Mastris; Chiara Benini; William M. Gallagher; Simonetta Buglioni; Alastair Kent; Elisabetta Munzone; Ivica Belina; Jan P. van Meerbeeck; Michael Joe Duffy; Elzbieta. Sarnowska; Beata Jagielska; Sarah Mee; Ettore Domenico Capoluongo

doi:10.20944/preprints202008.0307.v1

Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

Version 1 : Received: 12 August 2020 / Approved: 14 August 2020 / Online: 14 August 2020 (04:27:45 CEST)

Rapid and continuing advances in biomarker testing are not being matched by take-up 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. One of the paradigmatic examples is BRCA1/2 testing in ovarian, breast, pancreatic and prostate cancers. Nevertheless, development is impeded by 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

Not displayed online.

Please leave your comment to this article below.

Mathematical equations can be typed in either LaTeX formats \\[ ... \\] or $$ ... $$, or MathML format <math> ... </math>. Try the LaTeX or MathML example.

Type equation:

Preview:

Copy equation into message below

Close menu

Please click a symbol to insert it into the message box below:

Please enter the link here:

Optionally, you can enter text that should appear as linked text:

Copy link into message below

Close menu

Please enter or paste the URL to the image here (please only use links to jpg/jpeg, png and gif images):

Copy image into message below

Close menu

Type author name or keywords to filter the list of references in this group (you can add a new citation under Bibliography):

No existing citations in Discussion Group

Wikify editor is a simple editor for wiki-style mark-up. It was written by MDPI for Sciforum in 2014. The rendering of the mark-up is based on Wiky.php with some tweaks. Rendering of mathematical equations is done with MathJax. Please send us a message for support or for reporting bugs.

Close menu

Please declare any conflicts of interest you may have with this paper, financial or otherwise.

I do not have a conflict of interest

I would like to declare a conflict of interest

Display my name on the website

Captcha

Renew

I accept the following conditions:

Comments must follow the standards of professional discourse and should focus on the scientific content of the article. Insulting or offensive language, personal attacks and off-topic remarks will not be permitted. Comments must be written in English. Preprints reserves the right to remove comments without notice. Readers who post comments are obliged to declare any competing interests, financial or otherwise.

* All users must log in before leaving a comment

Notify me about updates to this article or when a peer-reviewed version is published.

Bringing onco-innovation to Europe’s healthcare systems: the unexploited potential of biomarker testing, real world evidence and the potential of Tumour Agnostics. The lesson from BRCA1/2 genetic testing

Abstract

Keywords

Subject

Comments (0)