BRECISE precision oncology biomarker research project

From biomarker discovery to clinical decision

BRECISE (Biomarker Research and Evaluation for Clinical Implementation and Supporting Systems Enhancement) is a European public–private partnership accelerating the clinical validation and adoption of innovative cancer biomarkers in prostate and bladder cancer.

Many promising cancer biomarkers never reach patients. The processes needed to validate them, align them with regulatory requirements, and integrate them into hospital practice are complex and slow. BRECISE brings together 25 partners across 15 European countries to validate five high-impact biomarkers and establish a structured framework that supports their safe and efficient implementation in healthcare systems.

The Challenge

Precision oncology aims to tailor treatment to the biological characteristics of each patient. Biomarkers are central to this approach. However, access to clinically validated prognostic and predictive biomarkers remains limited.

Prostate cancer is the most commonly diagnosed cancer in men in the EU and shows significant disparities in outcomes across countries. 

Bladder cancer remains highly prevalent, with substantial progression rates and treatment-related burden.

Despite scientific advances…

Many biomarkers lack sufficient large-scale clinical validation
Clinicians cannot reliably predict who will benefit from specific treatments
Patients may be overtreated or exposed to ineffective therapies.
Regulatory and health technology assessment pathways are complex
Integration of NGS and multi-modal AI tools into hospital workflows remains challenging

BRECISE addresses these barriers by validating biomarkers in real clinical environments and aligning scientific, technical, regulatory and health system requirements.

Our Mission

Together, we transform biomarker science into real-world healthcare solutions.

BRECISE focuses on prostate and bladder cancer and aims to strengthen biomarker-driven approaches for:

  • Patient risk stratification
  • Disease progression prediction
  • Treatment response assessment
  • Clinical decision support

By combining scientific validation, regulatory engagement, and real-world implementation, BRECISE supports the practical delivery of precision medicine in oncology.

What we aim to achieve

Improve risk stratification in prostate cancer, supporting safer active surveillance and better treatment selection.
Predict treatment response in bladder cancer, enabling earlier adjustments and improved patient outcomes.
Reduce unnecessary and ineffective treatments, lowering toxicity and improving quality of life.
Establish a structured biomarker validation and qualification framework aligned with regulatory and HTA requirements.

Our Five Clinical Use Cases

To demonstrate real-world impact, BRECISE validates five concrete biomarker use cases in prostate and bladder cancer, each addressing a specific unmet clinical need.

Prostate Cancer – Active Surveillance

Validating the PDE4D7 biomarker to improve risk stratification in men under active surveillance. Goal: Identify patients at higher risk of progression and reduce unnecessary biopsies

Prostate Cancer – Treatment Response

Validating the PDE4D7 biomarker to improve risk stratification in men under active surveillance. Goal: Identify patients at higher risk of progression and reduce unnecessary biopsies

Bladder Cancer – BCG Response

Validating the PDE4D7 biomarker to improve risk stratification in men under active surveillance. Goal: Identify patients at higher risk of progression and reduce unnecessary biopsies

Bladder Cancer – Immunotherapy Response

Validating liquid biopsy-based biomarkers to predict response to immune checkpoint inhibitors in metastatic bladder cancer. Goal: Enable earlier treatment adaptation and reduce unnecessary toxicity.

Prostate Cancer – Workflow Integration

Developing and validating a prototype-driven clinical decision support system integrating biomarker data into routine clinical workflows. Goal: Support real-world adoption of biomarker-guided care

Latest news

BRECISE precision oncology biomarker research project

BRECISE Overview

The project aims to accelerate the clinical validation and implementatioon of Next-Generation Sequencing….

Media & Resources

Videos

Interviews with clinical and scientific partners explaining the objectives and impact of each use case.

Newsletters

Biannual updates summarising clinical progress, regulatory developments and stakeholder engagement.

Publications

Open access reports, deliverables and scientific outputs.

The Partners

BRECISE brings together 25 academic, clinical, industrial and policy partners from 15 European countries.

The consortium combines expertise in oncology, genomics, artificial intelligence, regulatory science, health technology assessment and clinical implementation.

Have questions?

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