BRECISE

Biomarker research and evaluation for clinical implementation and supporting systems enhancement

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

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MedTech 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
NameEU funding in €
3d-Pharmxchange BV581 250
Agenzia Di Tutela Della Salute Della Brianza200 000
Associazione Italiana Malati Di Cancro, Parenti E Amici109 976
Atrys Health, SA423 230
Bioclavis Limited1 181 750
Biocomputing Platforms LTD Oy460 000
Bridg Ou529 250
Crown Bioscience Netherlands BV481 000
Dedalus Italia S.P.A.902 038
Elliniki Omospondia Karkinou Ell Ok220 881
Erasmus Universitair Medisch Centrum Rotterdam839 976
European Alliance for Personalised Medicine493 750
Genomate Health Hungary Kft.416 185
Hub Organoids BV928 470
Mutualite Fonction Publique Action Sante Social323 610
Ohmx.Bio570 609
Philips Electronics Nederland BV1 129 513
Predictby Research And Consulting S.L.410 375
Region Stockholm356 250
Servicio Andaluz De Salud108 401
South East Technological University925 275
Stichting Radboud Universitair Medisch Centrum664 334
Uab Cureline Baltic431 875
Universidad Complutense De Madrid301 688
Vastra Gotalandsregionen337 500
 
Third parties
NameFunding in €
Fundacion Para La Investigacion De Malaga En Biomedicina Y Salud288 750
 
Total Cost13 615 936