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 RNA and DNA.

The BRECISE framework will set out a systematic integrated approach to biomarker development with the goal of delivering clinical applications. This framework highlights the importance of generating high-quality, reproducible, actionable scientific knowledge at all stages of the process. Scientifically, the framework integrates all the technologies needed to develop and validate biomarkers. From the regulatory perspective, the framework seeks to harmonise 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.

As a core outcome of the BRECISE project, four novel biomarkers will be tested and validated through the framework; these have the potential to dramatically transform and improve the care of people living with prostate or bladder cancer.

In the field of prostate cancer, the PDE4D7 biomarker 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 is a promising biomarker for identifying patients with aggressive forms of prostate cancer; it could help to identify patients most likely to benefit from a combination of androgen deprivation therapy (ADT) and androgen receptor signalling inhibitors (ARSIs).

In the field of bladder cancer, the BCAI ImmunoScore could determine 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 (metastatic cancer) will respond to drugs called immune checkpoint inhibitors, offering hope for a tailored treatment strategy.

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 to develop innovative biomarkers will boost the competitiveness of Europe’s health research sector.