What is Brecise
BRECISE (Biomarker Research and Evaluation for Clinical Implementation and Supporting Systems Enhancement) is an ambitious, international research initiative dedicated to advancing biomarker research and ensuring its clinical implementation to improve patient care. Funded under the Horizon Europe Innovative Health Initiative Joint Undertaking (IHI JU), the project unites leading experts from academia, healthcare institutions, industry, and regulatory bodies to bridge the gap between biomedical innovation and real-world healthcare applications.
With the rapid growth of precision medicine, there is an urgent need to ensure that biomarker-driven diagnostic and therapeutic solutions are not only scientifically validated but also seamlessly integrated into clinical workflows. BRECISE aims to establish standardized testing methods, refine regulatory pathways, and foster collaboration among stakeholders. By ensuring reliability, accessibility, and widespread adoption, BRECISE is paving the way for faster diagnoses, more effective treatments, and improved patient outcomes
Why do biomarkers matter?
Biomarkers are biological indicators that provide critical insights into diseases, enabling earlier detection, accurate diagnosis, and tailored treatment selection. These indicators—ranging from genes and proteins to molecules found in bodily fluids—are revolutionizing medicine by shifting from a “one-size-fits-all” approach to a personalized treatment model.
In oncology, biomarker testing helps determine which patients will respond to targeted therapies, sparing them from ineffective treatments and unnecessary side effects. Similarly, in neurology and cardiovascular medicine, biomarkers aid in early disease detection, allowing timely interventions that improve patient outcomes.
By accelerating biomarker adoption, BRECISE aims to reduce misdiagnoses, lower healthcare costs, and increase treatment effectiveness. The project is dedicated to ensuring that biomarker-based innovations translate into tangible benefits for healthcare professionals and patients worldwide.
BRECISE’s approach: Translating research into real-world healthcare
Despite significant advances in biomarker discovery, clinical implementation faces barriers such as inconsistent testing methods, regulatory challenges, and limited awareness among healthcare providers. BRECISE is tackling these through a multi-faceted approach that includes:
Developing and standardizing biomarker testing protocols
BRECISE is working to refine and harmonize biomarker testing methodologies to ensure accuracy, reproducibility, and consistency across different laboratories and healthcare systems. Standardized testing is crucial for widespread clinical adoption and regulatory approval.
Bridging the gap between research and regulation
One of the greatest challenges in biomarker adoption is navigating regulatory frameworks. BRECISE is actively collaborating with regulatory agencies, including the European Medicines Agency (EMA) and national health authorities, to streamline the approval process for biomarker-driven diagnostic and therapeutic tools
Integrating biomarkers into healthcare systems
Regulatory approval alone is not enough—healthcare systems must be equipped to integrate biomarker-based testing into routine clinical workflows. BRECISE partners with hospitals, laboratories, and policymakers to develop implementation frameworks that make biomarker-based precision medicine accessible to all patients.
Leveraging AI and digital health solutions
BRECISE incorporates advanced AI and data analytics to improve biomarker interpretation, patient stratification, and treatment recommendations. Digital health solutions, such as real-world evidence platforms and AI-powered diagnostics, ensure that biomarkers are used efficiently in clinical decision-making.
Engaging key stakeholders to drive adoption
A critical component of BRECISE’s mission is raising awareness and educating healthcare professionals, patients, and decision-makers about the benefits of biomarker testing. Through training programs, clinical guidelines, and targeted outreach, the project ensures that biomarker-driven approaches become a fundamental part of modern healthcare.
What BRECISE brings for the future of healthcare?
The integration of biomarkers into healthcare has the potential to revolutionize medical practice by making diagnoses faster, treatments more effective, and healthcare systems more efficient. By reducing reliance on trial-and-error medicine, biomarker-based precision medicine ensures that every patient receives the right treatment at the right time.
BRECISE is not just about advancing biomarker research—it is about ensuring that scientific discoveries translate into real-world healthcare improvements. By fostering collaboration between scientists, clinicians, industry leaders, and policymakers, the project is helping bridge the gap between discovery and implementation.
As global healthcare systems face rising disease burdens and increasing costs, biomarker-driven solutions offer a transformative opportunity. BRECISE represents a groundbreaking step toward the future of personalized medicine, ensuring that precision medicine becomes the standard of care rather than an exception.
Who funds BRECISE?
BRECISE is financially supported by the European Commission under the Horizon Europe IHI JU program, one of Europe’s most prestigious research funding frameworks. The project has a total budget of €22,872,818.75 and will be implemented over a five-year period (January 1, 2025 – December 31, 2029).
As an EU-funded initiative, BRECISE operates under strict ethical and regulatory guidelines, ensuring scientific integrity, patient safety, and compliance with European data protection laws (GDPR, EHDS, Data Act). The project also follows the FAIR principles (Findable, Accessible, Interoperable, and Reusable) for data-sharing and transparency.
Project deliverables
The project is divided into work packages (WP), each with specific project deliverables:
WP1 – Project Management & Coordination
WP2 – Biomarker Discovery & Development
WP3 – Laboratory Validation & Clinical Trials
WP4 – Regulatory Strategy & Market Access
WP5 – Data Management & Standardization
WP6 – Ethical Compliance & Patient Engagement
WP7 – Dissemination & Policy Recommendations
Project timeline & milestones
Year 1-2: Biomarker discovery & validation
BRECISE focuses on identifying and validating biomarkers that can improve disease diagnosis and treatment. This phase includes laboratory testing, clinical sample analysis, and biomarker cross-validation to confirm their reliability.
Year 3: Clinical trials & regulatory discussions
Validated biomarkers enter clinical trials, where their safety, efficacy, and clinical utility are rigorously evaluated. BRECISE also engages with regulatory agencies to navigate approval pathways.
Year 4: Policy engagement & healthcare implementation
Successful biomarkers are integrated into healthcare systems, with discussions on reimbursement strategies, national health service adoption, and clinical workflow integration.
Year 5: Final evaluation & sustainability planning
The final phase assesses the real-world impact of biomarker-driven diagnostics and ensures that findings are accessible for future research and healthcare advancements.