ESMO basic requirements for AI-based biomarkers in oncology (EBAI)

M Aldea¹, M Salto-Tellez², A Marra³, R Umeton⁴, A Stenzinger⁵, M Koopman⁶, A Prelaj⁷, K L Kehl⁸, S Gilbert⁹, M-E Leßmann⁹, J Lipkova¹⁰, L Provenzano⁷, F Meric-Bernstam¹¹, S Halabi¹², J Wu¹³, A Pellat¹⁴, K P M Suijkerbuijk⁶, B Besse¹⁵, B Ryll¹⁶, C Marchió¹⁷, M Crispin-Ortuzar¹⁸, R Fehrmann¹⁹, J Vibert²⁰, D Ferber²¹, C Pauli²², A Valachis²³, F Corso²⁴, T J Brinker²⁵, J Mateo²⁶, N Harbeck²⁷, E C Winkler²⁸, F Lopez-Rios²⁹, R Perez-Lopez³⁰, G Pentheroudakis³¹, S Delaloge³², C Benedikt Westphalen³³, J N Kather³⁴

Affiliations

¹ Department of Cancer Medicine, Gustave Roussy, Villejuif, France; Faculty of Medicine, Paris-Saclay University, Kremlin Bicêtre, France; Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Boston, USA.
² Patrick G Johnston Centre for Cancer Research, Queen's University Belfast, Belfast, UK; Joint Integrated Pathology Unit, The Institute of Cancer Research, The Royal Marsden NHS Foundation Trust, London, UK.
³ Division of Early Drug Development for Innovative Therapies, European Institute of Oncology IRCCS, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milano, Milan, Italy.
⁴ Office of Data Science, St. Jude Children's Research Hospital, Memphis, USA; Department of Biological Engineering, Massachusetts Institute of Technology, Cambridge, USA; Department of Mechanical Engineering, Massachusetts Institute of Technology, Cambridge, USA; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, USA; Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, USA.
⁵ Institute of Pathology, University Hospital Heidelberg and Center for Personalized Medicine (ZPM), Heidelberg, Germany.
⁶ Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
⁷ AI-ON-Lab, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy; Department of Electronics, Information and Bioengineering, Politecnico di Milano, Milan, Italy.
⁸ Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Boston, USA.
⁹ Else Kroener Fresenius Center for Digital Health, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany.
¹⁰ Department of Pathology and Laboratory Medicine, University of California Irvine, Irvine, USA; Department of Biomedical Engineering, University of California Irvine, Irvine, USA; Department of Chao Family Comprehensive Cancer Center, UC Health, Orange, USA.
¹¹ Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, USA.
¹² Department of Biostatistics and Bioinformatics, Duke University, Durham, USA; Duke Cancer Institute, Duke University, Durham, USA.
¹³ Department of Imaging Physics, The University of Texas MD Anderson Cancer Center, Houston, USA; Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA.
¹⁴ Department of Gastroenterology, Endoscopy and Digestive Oncology Unit, Cochin Hospital AP-HP, Paris, France.
¹⁵ Department of Cancer Medicine, Gustave Roussy, Villejuif, France; Faculty of Medicine, Paris-Saclay University, Kremlin Bicêtre, France.
¹⁶ Melanoma Patient Network Europe, Uppsala, Sweden.
¹⁷ Department of Medical Sciences, University of Turin, Turin, Italy; Division of Pathology, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy.
¹⁸ Cancer Research UK Cambridge Centre, University of Cambridge, Cambridge, UK; Department of Oncology, University of Cambridge, Cambridge, UK.
¹⁹ Department of Medical Oncology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
²⁰ Drug Development Department, Gustave Roussy, Villejuif, France.
²¹ Medical Oncology, National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany.
²² Department of Pathology and Molecular Pathology, University Hospital Zurich and Medical Faculty, University of Zurich, Zurich, Switzerland.
²³ Department of Oncology, Faculty of Medicine and Health, Örebro University Hospital, Örebro University, Örebro, Sweden.
²⁴ AI-ON-Lab, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
²⁵ Division of Digital Prevention, Diagnostics and Therapy Guidance, Deutsches Krebsforschungszentrum (DKFZ), Heidelberg, Germany.
²⁶ Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain; Department of Medical Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.
²⁷ Breast Centre, Department of Obstetrics & Gynaecology and Comprehensive Cancer Centre Munich, LMU University Hospital, Munich, Germany.
²⁸ Institute for Medical and Data Ethics, Medical Faculty, Heidelberg University and Medical Oncology, National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany.
²⁹ Pathology Department, Hospital Universitario 12 de Octubre, Universidad Complutense de Madrid, Research Institute Hospital 12 de Octubre (imas12), CIBERONC, Madrid, Spain.
³⁰ Radiomics Group, Vall d'Hebron Institute of Oncology, (VHIO), Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
³¹ Scientific and Medical Division, European Society for Medical Oncology (ESMO), Lugano, Switzerland.
³² Department of Cancer Medicine, Gustave Roussy, Villejuif, France.
³³ Comprehensive Cancer Center Munich & Department of Medicine III, University Hospital, LMU Munich, Munich, Germany; German Cancer Consortium (DKTK), Partner Site Munich, German Cancer Research Center (DKFZ), Heidelberg, Germany. Electronic address: medicalaffairs@esmo.org.
³⁴ Else Kroener Fresenius Center for Digital Health, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany; Medical Oncology, National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany; Pathology & Data Analytics, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK. Electronic address: medicalaffairs@esmo.org.

PMID: 41260261
DOI: 10.1016/j.annonc.2025.11.009

Free article

ESMO basic requirements for AI-based biomarkers in oncology (EBAI)

M Aldea et al. Ann Oncol. 2025.

Free article

. 2025 Nov 18:S0923-7534(25)06267-2.

doi: 10.1016/j.annonc.2025.11.009. Online ahead of print.

Authors

Affiliations

¹ Department of Cancer Medicine, Gustave Roussy, Villejuif, France; Faculty of Medicine, Paris-Saclay University, Kremlin Bicêtre, France; Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Boston, USA.
² Patrick G Johnston Centre for Cancer Research, Queen's University Belfast, Belfast, UK; Joint Integrated Pathology Unit, The Institute of Cancer Research, The Royal Marsden NHS Foundation Trust, London, UK.
³ Division of Early Drug Development for Innovative Therapies, European Institute of Oncology IRCCS, Milan, Italy; Department of Oncology and Hemato-Oncology, University of Milano, Milan, Italy.
⁴ Office of Data Science, St. Jude Children's Research Hospital, Memphis, USA; Department of Biological Engineering, Massachusetts Institute of Technology, Cambridge, USA; Department of Mechanical Engineering, Massachusetts Institute of Technology, Cambridge, USA; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, USA; Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, USA.
⁵ Institute of Pathology, University Hospital Heidelberg and Center for Personalized Medicine (ZPM), Heidelberg, Germany.
⁶ Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
⁷ AI-ON-Lab, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy; Department of Electronics, Information and Bioengineering, Politecnico di Milano, Milan, Italy.
⁸ Lowe Center for Thoracic Oncology, Dana-Farber Cancer Institute, Boston, USA.
⁹ Else Kroener Fresenius Center for Digital Health, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany.
¹⁰ Department of Pathology and Laboratory Medicine, University of California Irvine, Irvine, USA; Department of Biomedical Engineering, University of California Irvine, Irvine, USA; Department of Chao Family Comprehensive Cancer Center, UC Health, Orange, USA.
¹¹ Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center, Houston, USA.
¹² Department of Biostatistics and Bioinformatics, Duke University, Durham, USA; Duke Cancer Institute, Duke University, Durham, USA.
¹³ Department of Imaging Physics, The University of Texas MD Anderson Cancer Center, Houston, USA; Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA.
¹⁴ Department of Gastroenterology, Endoscopy and Digestive Oncology Unit, Cochin Hospital AP-HP, Paris, France.
¹⁵ Department of Cancer Medicine, Gustave Roussy, Villejuif, France; Faculty of Medicine, Paris-Saclay University, Kremlin Bicêtre, France.
¹⁶ Melanoma Patient Network Europe, Uppsala, Sweden.
¹⁷ Department of Medical Sciences, University of Turin, Turin, Italy; Division of Pathology, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy.
¹⁸ Cancer Research UK Cambridge Centre, University of Cambridge, Cambridge, UK; Department of Oncology, University of Cambridge, Cambridge, UK.
¹⁹ Department of Medical Oncology, University Medical Centre Groningen, University of Groningen, Groningen, The Netherlands.
²⁰ Drug Development Department, Gustave Roussy, Villejuif, France.
²¹ Medical Oncology, National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany.
²² Department of Pathology and Molecular Pathology, University Hospital Zurich and Medical Faculty, University of Zurich, Zurich, Switzerland.
²³ Department of Oncology, Faculty of Medicine and Health, Örebro University Hospital, Örebro University, Örebro, Sweden.
²⁴ AI-ON-Lab, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.
²⁵ Division of Digital Prevention, Diagnostics and Therapy Guidance, Deutsches Krebsforschungszentrum (DKFZ), Heidelberg, Germany.
²⁶ Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain; Department of Medical Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.
²⁷ Breast Centre, Department of Obstetrics & Gynaecology and Comprehensive Cancer Centre Munich, LMU University Hospital, Munich, Germany.
²⁸ Institute for Medical and Data Ethics, Medical Faculty, Heidelberg University and Medical Oncology, National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany.
²⁹ Pathology Department, Hospital Universitario 12 de Octubre, Universidad Complutense de Madrid, Research Institute Hospital 12 de Octubre (imas12), CIBERONC, Madrid, Spain.
³⁰ Radiomics Group, Vall d'Hebron Institute of Oncology, (VHIO), Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain.
³¹ Scientific and Medical Division, European Society for Medical Oncology (ESMO), Lugano, Switzerland.
³² Department of Cancer Medicine, Gustave Roussy, Villejuif, France.
³³ Comprehensive Cancer Center Munich & Department of Medicine III, University Hospital, LMU Munich, Munich, Germany; German Cancer Consortium (DKTK), Partner Site Munich, German Cancer Research Center (DKFZ), Heidelberg, Germany. Electronic address: medicalaffairs@esmo.org.
³⁴ Else Kroener Fresenius Center for Digital Health, Faculty of Medicine and University Hospital Carl Gustav Carus, TUD Dresden University of Technology, Dresden, Germany; Medical Oncology, National Center for Tumor Diseases (NCT), University Hospital Heidelberg, Heidelberg, Germany; Pathology & Data Analytics, Leeds Institute of Medical Research at St James's, University of Leeds, Leeds, UK. Electronic address: medicalaffairs@esmo.org.

PMID: 41260261
DOI: 10.1016/j.annonc.2025.11.009

Abstract

Background: Artificial intelligence (AI) is expected to introduce an increasing number of biomarkers in oncology. To bridge the gap between oncology and computer science, it is timely to define recommendations for AI-based biomarkers suitable for routine clinical use. Here, we propose the ESMO (European Society for Medical Oncology) Basic Requirements for AI-based Biomarkers In Oncology (EBAI).

Design: The EBAI framework was developed using a modified Delphi methodology, involving a multidisciplinary panel of 37 experts who participated in four structured consensus rounds.

Results: AI-based biomarkers were classified as 'class A' (AI quantification of established biomarkers), 'class B' (indirect measure of known biomarkers using AI-based alternative methods, to be deployed as pre-screening tests), and 'class C' (novel AI-derived biomarkers, with C1 for prognosis and C2 for prediction of treatment effect). The EBAI framework addresses AI biomarkers for clinical use. Ground truth, performance, and generalisability were considered essential; fairness was recommended. Minimal validation requirements indicate that class A requires concordance studies, class B analytical validation, class C1 high-quality retrospective real-world or clinical trial data, and class C2 additionally requires clinical validation in prospective clinical trials for the prediction of response to a new treatment. All biomarker studies should report multiple evaluation and calibration metrics, with a clearly defined primary objective. Generalisability should be demonstrated across all intended use settings, including variability in data acquisition, post-processing, and population characteristics. Biomarkers must not be applied to other cancer types or modalities without supporting evidence.

Conclusions: EBAI defines criteria for AI-based biomarker adoption in routine use, providing a common language for physicians, AI developers, and researchers.

Keywords: EBAI; artificial intelligence; biomarker; cancer; scale; validation.

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ESMO basic requirements for AI-based biomarkers in oncology (EBAI)

Affiliations

ESMO basic requirements for AI-based biomarkers in oncology (EBAI)

Authors

Affiliations

Abstract

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Miscellaneous