Evidence map›Paper›PMID 40634781›Full record

ArticleNature medicine2025

Real-world deployment of a fine-tuned pathology foundation model for lung cancer biomarker detection.

Gabriele Campanella, Neeraj Kumar, Swaraj Nanda, Siddharth Singi, Eugene Fluder, Ricky Kwan, Silke Muehlstedt, Nicole Pfarr, Peter J Schüffler, Ida Häggström and 16 more

Abstract read
In one paragraph

Article in Nature medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 44 papers.

0numbers the graph read from it
0cells of the map it votes in
44citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

44 citing papers in PubMed.

  1. Article
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  11. Regulatory science for AI-basedJournal of pathology informatics · 2026
    Article
  12. Dissecting and directing pathology foundation models.bioRxiv : the preprint server for biology · 2026
    Article
  13. Article
  14. Review
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  19. Observational
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors.

Gabriele CampanellaWindreich Department of AI and Human Health, Icahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID http://orcid.org/0000-0001-6299-1311
Neeraj KumarDepartment of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Swaraj NandaDepartment of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Siddharth SingiDepartment of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID http://orcid.org/0009-0005-6184-5239
Eugene FluderScientific Computing and Data, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Ricky KwanDepartment of Pathology, Molecular and Cell-Based Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Silke MuehlstedtWindreich Department of AI and Human Health, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Nicole PfarrInstitute of Pathology, Technical University of Munich, Munich, Germany.ORCID http://orcid.org/0000-0002-5977-5375
Peter J SchüfflerInstitute of Pathology, Technical University of Munich, Munich, Germany.ORCID http://orcid.org/0000-0002-1353-8921
Ida HäggströmDepartment of Electrical Engineering, Chalmers University of Technology, Gothenburg, Sweden.ORCID http://orcid.org/0000-0001-9178-6683
Noora NeittaanmäkiDepartment of Clinical Pathology, Sahlgrenska University Hospital, Gothenburg, Sweden.ORCID http://orcid.org/0000-0002-8733-5510
Levent M AkyürekDepartment of Clinical Pathology, Sahlgrenska University Hospital, Gothenburg, Sweden.
Alina BasnetDepartment of Hematology and Oncology, SUNY Upstate Medical University, Syracuse, NY, USA.ORCID http://orcid.org/0000-0002-0062-9007
Tamara JamaspishviliDepartment of Hematology and Oncology, SUNY Upstate Medical University, Syracuse, NY, USA.ORCID http://orcid.org/0000-0002-1475-5717
Michel R NasrDepartment of Hematology and Oncology, SUNY Upstate Medical University, Syracuse, NY, USA.
Matthew M CrokenDepartment of Pathology, Molecular and Cell-Based Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Fred R HirschTisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Arielle ElkriefDepartment of Hematology-Oncology, University of Montreal Hospital Centre, Montreal, Quebec, Canada.
Helena YuDepartment of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID http://orcid.org/0000-0002-0377-9510
Orly ArdonDepartment of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID http://orcid.org/0000-0001-8147-933X
Gregory M GoldgofDepartment of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Meera HameedDepartment of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Jane HouldsworthDepartment of Pathology, Molecular and Cell-Based Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.ORCID http://orcid.org/0000-0002-6781-1700
Maria ArcilaDepartment of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.ORCID http://orcid.org/0000-0001-5824-6554
Thomas J Fuchs *Windreich Department of AI and Human Health, Icahn School of Medicine at Mount Sinai, New York, NY, USA. thomas.fuchs.ai@mssm.org.ORCID http://orcid.org/0000-0001-7603-8687
Chad Vanderbilt *Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA. vanderbc@mskcc.org.ORCID http://orcid.org/0000-0002-8114-0237

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Hongbiao Carl Lekaye · 1985 to 2026
$347.4M
Conduits: Mount Sinai Health System Translational Science HubUL1TR004419 · NCATS · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · PI Rosalind J Wright · 2022 to 2026
$46.4M
NCATS NIH HHS UL1 TR004419NCI NIH HHS P30 CA008748U.S. Department of Health & Human Services | NIH | National Cancer Institute (NCI) P30CA008748
6 · The paper itself

Abstract

Artificial intelligence models using digital histopathology slides stained with hematoxylin and eosin offer promising, tissue-preserving diagnostic tools for patients with cancer. Despite their advantages, their clinical utility in real-world settings remains unproven. Assessing EGFR mutations in lung adenocarcinoma demands rapid, accurate and cost-effective tests that preserve tissue for genomic sequencing. PCR-based assays provide rapid results but with reduced accuracy compared with next-generation sequencing and require additional tissue. Computational biomarkers leveraging modern foundation models can address these limitations. Here we assembled a large international clinical dataset of digital lung adenocarcinoma slides (N = 8,461) to develop a computational EGFR biomarker. Our model fine-tunes an open-source foundation model, improving task-specific performance with out-of-center generalization and clinical-grade accuracy on primary and metastatic specimens (mean area under the curve: internal 0.847, external 0.870). To evaluate real-world clinical translation, we conducted a prospective silent trial of the biomarker on primary samples, achieving an area under the curve of 0.890. The artificial-intelligence-assisted workflow reduced the number of rapid molecular tests needed by up to 43% while maintaining the current clinical standard performance. Our retrospective and prospective analyses demonstrate the real-world clinical utility of a computational pathology biomarker.

Indexed as

Adenocarcinoma of LungBiomarkers, TumorLung NeoplasmsArtificial IntelligenceErbB ReceptorsFemaleHumansMaleMutationBiomarkers, TumorEGFR protein, humanErbB Receptors

Identifiers

PMID40634781
PMCPMC12443599

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.