BRECISE

When someone is diagnosed with cancer, it is very hard to predict how their disease will progress, and which treatments are most likely to be effective. We urgently need new, clinically validated biomarkers to provide patients with better, more personalised care, and make health systems more efficient.

Enter the BRECISE project, which aims to deliver a framework and platform to accelerate the clinical validation of cancer biomarkers and related technologies. The project will concentrate in particular on biomarkers based on advanced technologies such as next-generation sequencing (NGS), which identifies specific alterations in tumour DNA and RNA.

A core output of the project will be the BRECISE framework, which sets out a systematic, integrated approach to biomarker development from discovery through to clinical use. The framework highlights the importance of generating high-quality, reproducible, actionable scientific knowledge at all stages of the process. On the scientific side, the framework will include all the technologies needed to develop and validate biomarkers. On the regulatory side, the framework will align definitions and expectations among stakeholders to ensure the successful adoption of the biomarkers.

The project will also deliver a comprehensive data integration platform. Built on data lake technologies, it will integrate different types of data, including clinical and biomarker data.

All of this will be built and tested using four novel biomarkers that could dramatically improve the care of people living with prostate or bladder cancer. PDE4D7 is a biomarker that could identify which prostate cancer patients managed with ‘active surveillance’ are at risk of disease progression and so would benefit from active treatment. Meanwhile the PCAI-ImmunoScore offers the hope of identifying patients with aggressive forms of prostate cancer most likely to benefit from a combination of androgen deprivation therapy (ADT) and androgen receptor signalling inhibitors (ARSIs).

In the bladder cancer field, the BCAI ImmunoScore could help to identify which patients with high-risk non-muscle invasive disease are likely to respond well to treatment with Bacillus Calmette-Guérin (BCG). Finally, NOV I/O BC is a biomarker that could predict how patients whose bladder cancer has spread to other parts of the body will respond to drugs called immune checkpoint inhibitors.

Biomarkers like these could revolutionise cancer care; patients will no longer have to go through a trial and error process to find a treatment that works for them, but will receive a more precise diagnosis and treatments tailored to their individual profile.

For health systems, better biomarkers will save resources as patient care is optimised. Finally, driving this effort on innovative biomarkers will boost the competitiveness of Europe’s health researchers.