BRECISE
A project for: European Union (Horizon Europe program)
BRIEF
The Challenge
BRECISE (Biomarker Research and Evaluation for Clinical Implementation and Supporting Systems Enhancement) is a multinational research initiative focused on advancing biomarker research and facilitating its integration into clinical practice to enhance patient care. Supported by the Horizon Europe Innovative Health Initiative Joint Undertaking (IHI JU), the project brings together experts from academia, healthcare, industry and regulatory agencies to close the gap between biomedical innovation and practical healthcare implementation.
As precision medicine evolves rapidly, there is an increasing need to ensure that biomarker-based diagnostic and therapeutic solutions are scientifically validated and effectively incorporated into clinical workflows. BRECISE seeks to develop standardised testing protocols, optimise regulatory frameworks and promote stakeholder collaboration. By prioritising reliability, accessibility and broad adoption, the project aims to accelerate diagnoses, improve treatment efficacy and support better patient outcomes.
FOCUS
The Approach
To achieve its goals, BRECISE combines scientific research with practical validation and stakeholder engagement. The project draws on systematic evidence reviews to map the current biomarker landscape and identify gaps, while also conducting pilots in clinical environments to understand how new solutions can be integrated into existing workflows. Through workshops, consultation and collaboration with healthcare professionals, regulators and patient organisations, BRECISE builds consensus and designs tools that are usable in real-world contexts. Digital innovation plays a key role, with new platforms and AI-driven models developed to support data analysis, clinical decision-making and standardisation across Europe.
CONCLUSIONS
The Envisioned Result
By the end of the project, BRECISE will deliver a framework for harmonised biomarker testing and clinical use. This includes practical guidelines, regulatory roadmaps and a digital platform to enable data sharing and AI-supported interpretation. The project also aims to build capacity through training and knowledge exchange, ensuring that healthcare professionals and stakeholders can effectively utilise the results. Ultimately, BRECISE aims to accelerate diagnosis, improve treatment effectiveness and enhance patient outcomes by embedding biomarker innovation into routine clinical practice.
PREDICTBY
Our Role
PredictBy is responsible for multiple tasks in this project as experts in biomarker-driven innovation and market and business strategy development.
Our role in the project consists of conducting the following tasks:
Leading a dedicated work package to analyse market opportunities, assess business potential and design a roadmap for the sustainable implementation of BRECISE results.
Supporting co-design, co-development and co-planning activities to ensure biomarkers, prototypes clinical studies are aligned with ethical, clinical and regulatory requirements.
Carrying out in-depth evaluations of product concepts, business models and competitor landscapes, complemented by cost-effectiveness and health technology assessments to demonstrate value and benefits for healthcare systems and patients.