Evidence map›Paper›PMID 39496972›Full record

ArticleNature medicine2025

Clinical validation of an AI-based pathology tool for scoring of metabolic dysfunction-associated steatohepatitis.

Hanna Pulaski, Stephen A Harrison, Shraddha S Mehta, Arun J Sanyal, Marlena C Vitali, Laryssa C Manigat, Hypatia Hou, Susan P Madasu Christudoss, Sara M Hoffman, Adam Stanford-Moore and 19 more

Abstract readValidation Study
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 29 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 1 pooled it
–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

29 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. AI-enabled clinical trials.Nature reviews bioengineering · 2026
    Article
  3. Review
  4. Drug Development for MASH-Related Compensated Cirrhosis: Past, Present and Future.Liver international : official journal of the International Association for the Study of the Liver · 2026
    Review
  5. Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. The Gut-Liver Axis in Metabolic Dysfunction-Associated Steatotic Liver Disease: From Mechanistic Insights to Precision Therapeutics.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2026
    Review
  11. Observational
  12. Article
  13. Article
  14. Review
  15. Review
  16. Article
  17. Review
  18. Review
  19. Review
  20. [Research progress and future prospects for artificial intelligence in the diagnosis and treatment of fatty liver disease].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2025
    Review
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

29 authors.

Hanna Pulaski *PathAI, Inc., Boston, MA, USA.ORCID 0000-0001-8092-0066
Stephen A Harrison *Pinnacle Clinical Research, San Antonio, TX, USA.ORCID 0000-0001-8285-2204
Shraddha S MehtaPathAI, Inc., Boston, MA, USA.
Arun J SanyalVirginia Commonwealth University, Richmond, VA, USA.ORCID 0000-0001-8682-5748
Marlena C VitaliPathAI, Inc., Boston, MA, USA.
Laryssa C ManigatPathAI, Inc., Boston, MA, USA.
Hypatia HouPathAI, Inc., Boston, MA, USA.
Susan P Madasu ChristudossPathAI, Inc., Boston, MA, USA.
Sara M HoffmanPathAI, Inc., Boston, MA, USA.
Adam Stanford-MoorePathAI, Inc., Boston, MA, USA.ORCID 0000-0002-0689-2607
Robert EggerPathAI, Inc., Boston, MA, USA.
Jonathan GlickmanPathAI, Inc., Boston, MA, USA.ORCID 0000-0003-0910-2655
Murray ResnickPathAI, Inc., Boston, MA, USA.
Neel PatelPathAI, Inc., Boston, MA, USA.
Cristin E TaylorPathAI, Inc., Boston, MA, USA.
Robert P MyersOrsoBio, Inc., Palo Alto, CA, USA.
Chuhan ChungInipharm, Inc., Bellevue, WA, USA.
Scott D PattersonGilead Sciences, Inc., Foster City, CA, USA.ORCID 0000-0002-9840-4964
Anne-Sophie SejlingNovo Nordisk, Bagsvaerd, Denmark.
Anne MinnichBristol Myers Squibb, Princeton, NJ, USA.
Vipul BaxiBristol Myers Squibb, Princeton, NJ, USA.
G Mani SubramaniamOrsoBio, Inc., Palo Alto, CA, USA.
Quentin M AnsteeTranslational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, UK.ORCID 0000-0002-9518-0088
Rohit LoombaUCSD School of Medicine, San Diego, CA, USA.ORCID 0000-0002-4845-9991
Vlad RatziuSorbonne Université, ICAN Institute for Cardiometabolism and Nutrition, Assisstance Publique Hôpitaux de Paris, INSERM UMRS, Paris, France.ORCID 0000-0002-6865-3791
Michael C MontaltoPathAI, Inc., Boston, MA, USA.
Nick P AndersonPathAI, Inc., Boston, MA, USA.
Andrew H BeckPathAI, Inc., Boston, MA, USA.ORCID 0000-0002-9978-134X
Katy E WackPathAI, Inc., Boston, MA, USA. katy.wack@pathai.com.ORCID 0009-0008-7761-3637

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Metabolic dysfunction-associated steatohepatitis (MASH) is a major cause of liver-related morbidity and mortality, yet treatment options are limited. Manual scoring of liver biopsies, currently the gold standard for clinical trial enrollment and endpoint assessment, suffers from high reader variability. This study represents the most comprehensive multisite analytical and clinical validation of an artificial intelligence (AI)-based pathology system, AI-based measurement of metabolic dysfunction-associated steatohepatitis (AIM-MASH), to assist pathologists in MASH trial histology scoring. AIM-MASH demonstrated high repeatability and reproducibility compared to manual scoring. AIM-MASH-assisted reads by expert MASH pathologists were superior to unassisted reads in accurately assessing inflammation, ballooning, MAS ≥ 4 with ≥1 in each score category and MASH resolution, while maintaining non-inferiority in steatosis and fibrosis assessment. These findings suggest that AIM-MASH could mitigate reader variability, providing a more reliable assessment of therapeutics in MASH clinical trials.

Indexed as

Artificial IntelligenceFatty LiverAdultBiopsyFemaleHumansLiverMaleMiddle AgedNon-alcoholic Fatty Liver DiseaseReproducibility of Results

Identifiers

PMID39496972
PMCPMC11750710

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.