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What practicing pathologists and oncologists should know about the new computational pathology‐based companion diagnostic tools

The Journal of Pathology, vol. 269, pp. 143–148

Abstract

The integration of artificial intelligence into pathology is transforming the assessment of histological and immunohistochemical (IHC) slides, offering opportunities to reduce variability and streamline diagnostics. In practical terms, most available tools and research models emulate the diagnostic capabilities of pathologists by detecting, grading, and classifying tumours and other diseases. More recent applications have moved beyond mimicry, aiming to predict established biomarkers, such as microsatellite instability or IHC-based markers, and to tackle even more ambitious tasks, such as directly predicting patient prognosis from H&E whole slide images. Remarkably, novel computational tools are now being designed as companion diagnostic assays, linking the automated evaluation of specific IHC biomarkers to the prediction of response to specific drugs, potentially marking a new chapter in the evolution of digital and computational pathology. The TROPION-PanTumor01 trial recently demonstrated the superiority of a supervised machine learning model (termed the quantitative continuous score [QCS] by the vendor) in assessing TROP2 IHC compared with human scoring, promising better stratification of patients with non-small cell lung cancer for treatment with datopotamab deruxtecan. The same approach has shown promise in refining HER2 (human epidermal growth factor receptor 2) and PD-L1 (programmed death-ligand 1) evaluations, revealing patient subgroups that may benefit from targeted therapies. Moreover, other similar approaches are progressively reaching the market, posing significant opportunities and challenges for clinicians involved in the care of patients with cancer. This Perspective is promoted by the European Society of Digital and Integrative Pathology (ESDIP, founded in 2016, and having long-standing experience in computational pathology, esdipath.org) and the European Interdisciplinary Society of Artificial Intelligence for Cancer Research (ESAC, a recently established initiative, founded in 2024, esac-network.eu), both bringing together clinicians, engineers and other professionals dedicated to the development and clinical translation of computational approaches aimed at improving patient care. It aims to provide an informed overview of novel computational pathology companion diagnostic tools, with a particular focus on the background that practicing pathologists and oncologists need to have with these tools, when transitioning from research to clinical practice, irrespective of their prior familiarity with computational approaches. © 2026 The Author(s). The Journal of Pathology published by John Wiley & Sons Ltd on behalf of The Pathological Society of Great Britain and Ireland.

Authors 12

  1. Instituto Português de Oncologia Francisco Gentil · IPO Porto · Centro de Investigação do Instituto Português de Oncologia do Porto Francisco Gentil · IMP Diagnostics (Portugal) · RISE - Health Research Network

    Affiliation as printed

    Cancer Biology and Epigenetics Group, Research Center of IPO Porto (CI‐IPOP) Portuguese Oncology Institute of Porto, Comprehensive Cancer Center Raquel Seruca (Porto.CCC) & CI‐IPOP@RISE (Health Research Network) Porto Portugal

    European Society of Digital and Integrative Pathology (ESDIP) Lisbon Portugal

    Research & Development Unit, IMP Diagnostics Porto Portugal

  2. The Netherlands Cancer Institute

    Affiliation as printed

    Computational Pathology Group, The Netherlands Cancer Institute Amsterdam The Netherlands

    European Society of Digital and Integrative Pathology (ESDIP) Lisbon Portugal

  3. University of Bern

    Affiliation as printed

    Department of Digital Medicine University of Bern Bern Switzerland

    European Society of Digital and Integrative Pathology (ESDIP) Lisbon Portugal

    Institute of Tissue Medicine and Pathology (ITMP), University of Bern Bern Switzerland

  4. Radboud University Nijmegen · Radboud University Medical Center

    Affiliation as printed

    Computational Pathology Group, Department of Pathology Radboud University Medical Center Nijmegen The Netherlands

    European Society of Digital and Integrative Pathology (ESDIP) Lisbon Portugal

  5. Vall d'Hebron Hospital Universitari

    Affiliation as printed

    European Society of Digital and Integrative Pathology (ESDIP) Lisbon Portugal

    Pathology Department, Vall Hebron University Hospital Barcelona Spain

  6. Haukeland University Hospital · University of Bergen

    Affiliation as printed

    Department of Clinical Medicine University of Bergen Bergen Norway

    Department of Pathology Haukeland University Hospital Bergen Norway

    European Society of Digital and Integrative Pathology (ESDIP) Lisbon Portugal

  7. Affiliation as printed

    European Society of Digital and Integrative Pathology (ESDIP) Lisbon Portugal

    ImginIT Paris France

  8. University of Medicine and Pharmacy of Craiova · University of Craiova

    Affiliation as printed

    Department of Medical Informatics and Biostatistics University of Medicine and Pharmacy of Craiova Craiova Romania

    European Society of Digital and Integrative Pathology (ESDIP) Lisbon Portugal

  9. Fondazione IRCCS Istituto Nazionale dei Tumori · Politecnico di Milano

    Affiliation as printed

    Department of Electronics, Information, and Bioengineering Polytechnic University of Milan Milan Italy

    European Interdisciplinary Society for AI in Cancer Research (ESAC) Milan Italy

    Thoracic Oncology Unit, Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori Milan Italy

  10. University of Leeds · University Hospital Heidelberg · National Center for Tumor Diseases · Else Kröner Fresenius Center for Digital Health · Technische Universität Dresden

    Affiliation as printed

    Department of Medicine I, Faculty of Medicine TUD Dresden University of Technology Dresden Germany

    Else Kröner Fresenius Center for Digital Health, Faculty of Medicine TUD Dresden University of Technology Dresden Germany

    European Interdisciplinary Society for AI in Cancer Research (ESAC) Milan Italy

    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

  11. Humboldt-Universität zu Berlin · Universitätsklinikum Aachen · Charité - Universitätsmedizin Berlin · RWTH Aachen University

    Affiliation as printed

    Charité ‐ Universitätsmedizin Berlin, corporate member of Freie Universität Berlin and Humboldt Universität zu Berlin Institute of Medical Informatics Berlin Germany

    European Society of Digital and Integrative Pathology (ESDIP) Lisbon Portugal

    Institute of Pathology RWTH Aachen University Hospital Aachen Germany

  12. Vincenzo L'Imperio corresponding

    University of Milano-Bicocca

    Affiliation as printed

    Department of Pathology Fondazione IRCCS San Gerardo dei Tintori Monza Italy

    European Society of Digital and Integrative Pathology (ESDIP) Lisbon Portugal

    School of Medicine and Surgery University of Milano‐Bicocca Milan Italy

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