Summary
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.
Participants
Show participants on mapMedTech Europe
- Bioclavis Limited, Clydebank, United Kingdom
- Genomate Health Hungary Kft., Budapest, Hungary
Universities, research organisations, public bodies, non-profit groups
- Agenzia Di Tutela Della Salute Della Brianza, Monza, Italy
- Elliniki Omospondia Karkinou Ell Ok, Athina, Greece
- Erasmus Universitair Medisch Centrum Rotterdam, Rotterdam, Netherlands
- European Alliance for Personalised Medicine, Maribor, Slovenia
- Mutualite Fonction Publique Action Sante Social, Paris, France
- Pharmaledger Association, Basel, Switzerland
- Region Stockholm, Stockholm, Sweden
- Servicio Andaluz De Salud, Sevilla, Spain
- South East Technological University, Waterford, Ireland
- Stichting Radboud Universitair Medisch Centrum, Nijmegen, Netherlands
- Udg Alliance, Lausanne, Switzerland
- Universidad Complutense De Madrid, Madrid, Spain
- Vastra Gotalandsregionen, Vanersborg, Sweden
COCIR
- Biocomputing Platforms LTD Oy, Espoo, Finland
- Dedalus Italia S.P.A., Firenze, Italy
- Medexprim, Labege, France
- Philips Electronics Nederland BV, Eindhoven, Netherlands
EuropaBio
- 3d-Pharmxchange BV, Tilburg, Netherlands
- Atrys Health, SA, Madrid, Spain
- Crown Bioscience Netherlands BV, Leiden, Netherlands
- Hub Organoids BV, Utrecht, Netherlands
- Ohmx.Bio, Gent, Belgium
- Uab Cureline Baltic, Vilnius, Lithuania
Patient organisations
- Associazione Italiana Malati Di Cancro, Parenti E Amici, Roma, Italy
Third parties
- Fundacion Para La Investigacion De Malaga En Biomedicina Y Salud, Malaga, Spain
Small and medium-sized enterprises (SMEs) and mid-sized companies (<€500 m turnover)
- Bridg Ou, Tallin, Estonia
- Novigenix SA, Epalinges, Switzerland
- Predictby Research And Consulting S.L., Barcelona, Spain
Participants | |
---|---|
Name | EU funding in € |
3d-Pharmxchange BV | 581 250 |
Agenzia Di Tutela Della Salute Della Brianza | 200 000 |
Associazione Italiana Malati Di Cancro, Parenti E Amici | 109 976 |
Atrys Health, SA | 423 230 |
Bioclavis Limited | 1 181 750 |
Biocomputing Platforms LTD Oy | 460 000 |
Bridg Ou | 529 250 |
Crown Bioscience Netherlands BV | 481 000 |
Dedalus Italia S.P.A. | 902 038 |
Elliniki Omospondia Karkinou Ell Ok | 220 881 |
Erasmus Universitair Medisch Centrum Rotterdam | 839 976 |
European Alliance for Personalised Medicine | 493 750 |
Genomate Health Hungary Kft. | 416 185 |
Hub Organoids BV | 928 470 |
Mutualite Fonction Publique Action Sante Social | 323 610 |
Ohmx.Bio | 570 609 |
Philips Electronics Nederland BV | 1 129 513 |
Predictby Research And Consulting S.L. | 410 375 |
Region Stockholm | 356 250 |
Servicio Andaluz De Salud | 108 401 |
South East Technological University | 925 275 |
Stichting Radboud Universitair Medisch Centrum | 664 334 |
Uab Cureline Baltic | 431 875 |
Universidad Complutense De Madrid | 301 688 |
Vastra Gotalandsregionen | 337 500 |
Third parties | |
Name | Funding in € |
Fundacion Para La Investigacion De Malaga En Biomedicina Y Salud | 288 750 |
Total Cost | 13 615 936 |