SIENA, Italy — Siena Imaging is proud to announce the official launch of GLIOGEN-X (“From Magnetic Resonance Imaging to Molecular Signatures: Generative AI for Virtual Biopsy in Gliomas”), a groundbreaking 4-year European research project aiming to pioneer non-invasive “virtual biopsies” for brain tumor patients.
Presented this week in Siena, GLIOGEN-X has been awarded €4 million in funding under the highly competitive EIC Pathfinder Challenges (Horizon Europe), specifically within the challenge dedicated to Generative-AI based Agents to Revolutionize Medical Diagnosis and Treatment of Cancer. GLIOGEN-X is one of only seven projects selected from 219 proposals submitted across Europe under this challenge.
Official project details can now be consulted on the European Commission’s CORDIS GLIOGEN-X Project Page.
Addressing a Critical Challenge in Neuro-Oncology
Gliomas are the most common primary malignant brain tumors in adults, accounting for over 27,700 new cases per year in Europe. Among them, glioblastoma represents the most aggressive form, with a median survival time of just 12–15 months. Furthermore, the number of new central nervous system cancer cases is projected to rise by nearly 50% globally by 2045.
Today, treatment choices depend largely on knowing the tumor’s molecular profile. However, obtaining this information currently requires a surgical biopsy—an invasive procedure that is not always feasible for fragile patients or when tumors reside in inaccessible, high-risk brain regions.
GLIOGEN-X addresses this clinical gap by investigating whether routine MRI scans contain hidden biological signatures of a glioma’s molecular subtype. Generative AI is used to test this hypothesis and to support a predictive model that estimates the molecular profile non-invasively. The long-term goal is a “virtual biopsy” for multidisciplinary tumor boards, available before surgery or when tissue sampling is not possible, to support earlier treatment planning.
Three Pillars of Innovation
Coordinated by Siena Imaging, the project will leverage MRI, clinical, pathological and molecular data from over 3,000 adult glioma patients provided by UK clinical centers: the Northern Care Alliance NHS Foundation Trust (NCA), linked to the University of Manchester, and the University of Sheffield. Building on Siena Imaging’s preliminary PNRR-funded research—which achieved a mean AUC of 0.85-0.90 in predicting key glioma molecular subtypes on an external test set—GLIOGEN-X will be built around three core pillars:
- Generative AI & Synthetic Data: Creating realistic synthetic MRI scans representing different glioma subtypes and assessing their suitability for sharing through European research repositories, while safeguarding patient privacy.
- Decoding Biological Signatures: Testing whether MRI carries recoverable information on tumor genetics, through a falsifiable design.
- Explainable AI & Federated Learning: Building trustworthy, interpretable AI algorithms (not “black-box”) trained via a Federated Learning infrastructure. This allows participating hospitals to collaborate on model training without transferring sensitive patient data. The infrastructure is designed to comply with Europe’s GDPR and AI Act.
Leadership & Perspectives
“We are deeply proud of this milestone,” says Prof. Nicola De Stefano, Full Professor of Neurology at the University of Siena and Co-Founder of Siena Imaging. “Siena Imaging was born from an academic research group with world-class expertise in neuroimaging analysis. High-level research is in our DNA—it is the core value driving our continuous growth as a company.”
Marco Battaglini, CEO and Co-Founder of Siena Imaging, emphasizes the clinical mission:
“Siena Imaging works to bridge the gap between academic research and clinical application, delivering practical, innovative solutions for patients and clinicians. Being selected for an EIC Pathfinder Challenge alongside top-ranked international institutions—such as the Karolinska Institutet or the German Cancer Research Center—confirms that even agile, highly specialized companies can lead frontier research in Europe.”
A Strong European Consortium
Siena Imaging serves as the project coordinator and lead AI developer. The consortium brings together prestigious international partners:
- Fondazione Toscana Life Sciences (TLS) – Exploitation, dissemination, communication management, ethics.
- The University of Manchester & Northern Care Alliance NHS Foundation Trust (UK) – Clinical validation and neuro-oncology expertise.
- Fundació per a la Universitat Oberta de Catalunya (Spain) – Architecture and implementation of the Federated Learning infrastructure.
Over the next four years, GLIOGEN-X aims to pave the way toward personalized and non-invasive diagnostic pathways for brain tumor patients across Europe and beyond.
Media Coverage & References
The public launch and strategic significance of GLIOGEN-X have been highlighted across regional and national news outlets, including coverage by Gazzetta di Siena, Il Cittadino Online, Siena News, and Antenna Radio Esse.
