Peer-Reviewed Publication
Mod Pathol2026;39(2):100944.February 1, 2026Journal Article

Agreement Across 10 Artificial Intelligence Models in Assessing Human Epidermal Growth Factor Receptor 2 (HER2) Expression in Breast Cancer Whole-Slide Images.

Brittany McKelvey1, Pedro A Torres-Saavedra2, Jessica Li2, Glenn Broeckx3, Frederik Deman3, Siraj Ali4, Hillary S Andrews1, Salim Arslan5, Meir Azulay6, Santhosh Balasubramanian7, J C Barrett8, Peter Caie9, Ming Chen10, Daniel Cohen11, Tathagata Dasgupta12, Diana Fahrer9, George Green13, Mark Gustavson14, Sarah Hersey15, Ana Hidalgo-Sastre16, Shahanawaz Jiwani17, Elaine Joseph18, Wonkyung Jung4, Kimary Kulig19, Vladimir Kushnarev20, Jochen K Lennerz20, Xiaoxian Li21, Meredith Lodge9, Joan Mancuso22, Mike Montalto23, Satabhisa Mukhopadhyay12, Foivos Ntelemis5, Matthew Oberley10, Pahini Pandya5, Oscar Puig6, Edward T Richardson24, Alexander Sarachakov20, Mark Stewart25, Lisa M McShane2, Roberto Salgado26, Jeff Allen1
1Friends of Cancer Research, Washington, District of Columbia.
2Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, Maryland.
3PA(2), Department of Pathology, Ziekenhuis aan de Stroom (ZAS), Antwerp, Belgium; Centre for Oncological Research (CORE), MIPPRO, Faculty of Medicine, Antwerp University, Antwerp, Belgium.
4Lunit, Seoul, South Korea.
5Panakeia Technologies, Cambridge, United Kingdom.
6Nucleai, Chicago, Illinois.
7PathAI, Boston, Massachusetts.
8University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
9Indica Labs, Albuquerque, New Mexico.
10Caris Life Sciences, Irving, Texas.
11GSK, Collegeville, Pennsylvania.
124D Path, Newton, Massachusetts.
13GA Green Consulting LLC, Newton, New Jersey.
14AstraZeneca, Gaithersburg, Maryland.
15Bristol Myers Squibb, Lawrenceville, New Jersey.
16AstraZeneca Computational Pathology GmbH, AstraZeneca, Munich, Germany.
17Molecular Characterization Laboratory, Frederick National Laboratory/National Cancer Institute, Frederick, Maryland.
18AstraZeneca, Waltham, Massachusetts.
19Kulig Consulting, New York, New York.
20BostonGene, Waltham, Massachusetts.
21Emory University, Atlanta, Georgia.
22Patient Advocate, Philadelphia, Pennsylvania.
23Amgen, Thousand Oaks, California.
24Merck & Co Inc, Boston, Massachusetts.
25Friends of Cancer Research, Washington, District of Columbia. Electronic address: mstewart@focr.org.
26PA(2), Department of Pathology, Ziekenhuis aan de Stroom (ZAS), Antwerp, Belgium; Division of Research, Peter Mac Callum Cancer Centre, Melbourne, Australia.

Abstract

Historically, eligibility for receiving human epidermal growth factor receptor 2 (HER2)-targeted therapies was limited to HER2-positive tumors (immunohistochemistry 3+ or in situ hybridization amplified), but recent advances in antibody-drug conjugates have expanded these criteria to include HER2-low and HER2-ultralow expression. This evolving therapeutic landscape underscores the need for precise…

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