BRUSSELS – [May 26, 2025] – A pivotal event, hosted on Tuesday, May 20, 2025 at the European Parliament by MEP Vlad (Vasile) Voiculescu (RENEW/Romania) and endorsed by MEP Letizia Moratti (EPP/Italy) and former MEP Paul Ruebig, convened leading policymakers, EU Commission officials, scientists, clinicians, and patient representatives to address the urgent need for integrating Next Generation Sequencing (NGS) into routine clinical practice across Europe
The High Level Seminar “Precision Diagnostics for Precision Cancer Care-Improving Patient Access to Innovation” showcased the achievements of the EU co-funded Instand-NGS4P project and called for urgent action to align regulation, reimbursement, and infrastructure for equitable patient access to personalized medicine. The Seminar underscored the growing consensus that precision medicine must be supported by equally precise diagnostics.
“Precision medicine without precision diagnostics is simply guesswork,” said MEP Vlad Voiculescu. “We need to remove the barriers that stop innovation from reaching patients.”
The discussions underscored the transformative potential of personalized medicine, particularly in oncology, and the collective commitment to ensuring equitable patient access. The Seminar highlighted that while NGS offers unprecedented opportunities to tailor treatments based on individual genetic profiles, its widespread adoption is currently hindered by significant challenges. These include navigating complex regulatory frameworks, overcoming barriers to cross-border data sharing, and establishing robust, harmonized reimbursement systems.
“European and international standards can markedly support bringing innovative diagnostic technologies such as Next Generation Sequencing or AI-based diagnostics to the market and patient.” said Professor Kurt Zatloukal of the Medical University of Graz, coordinator of Instand-NGS4P. “This is achieved by defining the state-of-the-art and, thereby, providing guidance for manufacturers and regulators.”
Key Takeaways from the Event:
- Accelerating Personalized Medicine in Europe: The event underscored the urgent need to integrate Next Generation Sequencing (NGS) into routine clinical practice across Europe to advance personalized medicine, particularly in oncology, and ensure equitable patient access.
- Addressing Key Implementation Barriers: Discussions highlighted critical challenges such as regulatory complexities (e.g., IVDR compliance), data sharing limitations (GDPR implications), and the need for robust, harmonized reimbursement systems to fully realize the potential of NGS.
- Collaborative European Strategy Essential: A strong consensus emerged on the necessity of a unified European approach, including initiatives like "Instand-NGS4P" and "1 Million Genomes," to build shared infrastructure, expertise, and overcome existing knowledge and best practice silos to enhance patient care.
- Patient-Centricity and Data Stewardship: The event emphasized that all advancements must be driven by patient needs, including clear communication, informed consent, and secure data handling models that maintain individual ownership of genetic information. Patient representatives reminded the audience that access to quality genomic testing is still not a reality for many across Europe. Without transparency on lab quality, turnaround time, and test interpretation, patients are often left navigating an opaque system.
"Our ultimate goal is to bridge the gap between scientific innovation and patient benefit. NGS offers unparalleled insights into diseases like cancer, allowing for truly personalized treatments. It’s about ensuring every patient has access to the best available diagnostics, guiding effective therapies, and improving outcomes across Europe," stated Prof. Francesco de Lorenzo, President of FAVO – Italian Federation of Volunteer Cancer Patient Associations.
Addressing the intricate landscape of regulations, Dr. Uwe Oelmueller, Vice President – PreAnalytiX Management Committee Co-Chair – QIAGEN GmbH – Germany, commented, "Innovative molecular diagnostics demonstrate tremendous potential, but accurate results depend heavily on the entire workflow—from patient specimen collection, transport, and processing through to the final laboratory test result, including data analysis. Following scientific evidence, international standards, and legal requirements, in vitro diagnostic test validation increasingly encompasses the entire workflow to improve safety and performance."
The economic imperative was also a central theme. Prof. Wim van Harten (em.), The Netherlands Cancer Institute, Amsterdam - Chair Working Group Health Economics, OECI and Endowed Professor Valesca Retèl – Health Technology Assessment – Erasmus School of Health Policy & Management, highlighted, "Harmonized and comprehensive evidence regarding short- and long-term consequences, combined with the integration of common assessment frameworks for broad genomic profiling into the Joint Clinical Technology Assessment, will promote equitable access to innovative treatments across Europe."
A Political Mandate for Action
In her concluding remarks, MEP Letizia Moratti, member of the EU Commission SANT Committee, expressed strong support for integrating the outcomes of the event into current legislative efforts at the EU level.
“This initiative is a meaningful contribution to improving clinical outcomes with next-generation technologies,” she said. “I will take your conclusions to the Parliament and Commission with full commitment.”
MEP Moratti also shared her own proposal submitted to the Commission for a European network to support systematic evaluation and access to innovative oncological therapies, which would complement the outcomes of Instand-NGS4P.
Prof. Marialuisa Lavitrano, School of Medicine and Surgery - University Milano-Bicocca – Italy summarizing the event discussions stated: “Cross-border access to genetic profiling is not merely a technical or financial issue—it's a question of equity, innovation, and public health cohesion. Through strategic alignment, shared standards, and EU-supported infrastructure, national systems can offer every patient access to cutting-edge genomic care, regardless of location”.
Concluding the impactful discussions, Prof. Kurt Zatloukal, Project Coordinator – Director – Diagnostic and Research Institute of Pathology – Medical University of Graz – Austria, remarked, "This event is a testament to the collaborative spirit required to transform healthcare. It’s a kickoff, not an end, to a crucial process. By bringing together policymakers, scientists, clinicians, and patient advocates, we build the broad consensus needed to translate cutting-edge science into tangible improvements for patients across Europe."
The Seminar concluded with a strong call for continued collaboration and a firm commitment to translating these crucial discussions into concrete actions, ultimately aiming to improve healthcare access and outcomes for patients throughout the European Union and invited all participants to contribute to the White Paper on the contents of the High Level Seminar to be available shortly after the event.
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About the Instand-NGS4P EU co-funded project:
The Instand-NGS4P project is a pre-commercial procurement initiative aimed at developing and integrating innovative Next Generation Sequencing solutions into routine clinical diagnosis to enhance personalized medicine across Europe. It brings together leading experts from academia, industry, and patient advocacy to address key challenges in diagnostic workflow, regulatory compliance, and reimbursement.
Project Website: https://www.instandngs4p.eu/
High Level Seminar Webpage: https://www.instandngs4p.eu/high-level-seminar/
Patient Resources: https://www.instandngs4p.eu/genetic-cancer-testing-resources-for-patients-and-families/
Contact:
Prof. Francesco de Lorenzo
President F.A.V.O. – Italian Federation
of Volunteer Cancer Patient Associations
mail: fdelorenzo@favo.it
tel. +39 6 42989576
website: favo.it
