Computer-Aided Quantitative Image Analysis of Multiple Human Epidermal Growth Factor Receptor 2 Immunohistochemistry Assays in Breast Carcinoma.

Context.--Quantitative image analysis (QIA) is increasingly applied for immunohistochemistry (IHC)-based biomarker assessment in pathology. With the introduction of drugs targeting breast carcinomas (BCs) with low human epidermal growth factor receptor 2 (HER2) expression levels, a need for more acc...

Full description

Bibliographic Details
Published in:Archives of Pathology & Laboratory Medicine Vol. 150; no. 8; pp. 610 - 620
Main Authors: Cossutta, Mélissande, Truumees, Birgit, Papine, Alexandre, Kristoffersen, Heidi Lykke, Tatarinova, Ekaterina, Emanuelsen, Lise, Homsy, Charles, Soussaline, Françoise, Nielsen, Søren
Format: pictorial research tables/charts Journal Article
Published: College of American Pathologists Aug2026
Online Access:View this record in EBSCOhost
fields @attributes:
  recordID: 1
pdfLink:
plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=196173101&site=ehost-live
header:
  @attributes:
    shortDbName: ccm
    uiTerm: 196173101
    longDbName: CINAHL Complete
    uiTag: AN
  controlInfo:
    bkinfo:
    dissinfo:
    jinfo:
      jid:
        00039985
        1FS
      jtl: Archives of Pathology & Laboratory Medicine
      issn: 00039985
      maglogo: N
    pubinfo:
      dt: Aug2026
      vid: 150
      iid: 8
      pid: 2550
      pub: College of American Pathologists
      place: Northfield, Illinois
    artinfo:
      ui:
        196173101
        196173101
        196173101
        10.5858/arpa.2025-0316-OA
        196173101
      ppf: 610
      ppct: 10
      formats:
        fmt:
          @attributes:
            type: P
      tig:
        atl: Computer-Aided Quantitative Image Analysis of Multiple Human Epidermal Growth Factor Receptor 2 Immunohistochemistry Assays in Breast Carcinoma.
      aug:
        au:
          Cossutta, Mélissande
          Truumees, Birgit
          Papine, Alexandre
          Kristoffersen, Heidi Lykke
          Tatarinova, Ekaterina
          Emanuelsen, Lise
          Homsy, Charles
          Soussaline, Françoise
          Nielsen, Søren
        affil: Research and Development Department, IMSTAR Dx, Paris, France
      sug:
        subj:
          Breast Neoplasms Pathology
          Epidermal Growth Factor Receptors
          Immunohistochemistry
          Image Processing, Computer Assisted
          Reproducibility of Results
          Human
          Pathologists
          Comparative Studies
          Validation Studies
          Staining and Labeling
          Sensitivity and Specificity
          Confidence Intervals
          Descriptive Statistics
          Tumor Markers, Biological
      ab: Context.--Quantitative image analysis (QIA) is increasingly applied for immunohistochemistry (IHC)-based biomarker assessment in pathology. With the introduction of drugs targeting breast carcinomas (BCs) with low human epidermal growth factor receptor 2 (HER2) expression levels, a need for more accurate and reproducible HER2 scoring is warranted. QIA has the potential to increase HER2 IHC scoring reproducibility. However, QIA reproducibility should be agnostic and uninfluenced by different IHC assays. Objective.--To compare HER2 scoring accuracy and reproducibility by expert pathologists and QIA in BCs analyzed with different IHC assays. Design.--Algorithm parameters of the QIA method were developed by using 183 slides from 6 Nordic immunohistochemical Quality Control (NordiQC) HER2 runs. The QIA method was then validated on 409 slides from 2 other runs. HER2 scores obtained by visual scoring, following 2023 European Society for Medical Oncology and American Society of Clinical Oncology/College of American Pathologists guidelines or by QIA, were compared. Results.--Visual scoring and QIA reached 86% (κ = 0.81) overall scoring agreement for tissue cores in the final validation material. QIA showed 98% (95% CI, 97.8%-99.0%) sensitivity and 84% (95% CI, 80.3%-87.6%) specificity for the distinction between HER2 0 (no drug candidate) and HER2 1-31 (drug candidates) scores. Ninety-nine percent (95% CI, 98.7%-99.9%) sensitivity and 100% (95% CI, 99.8%-100%) specificity were obtained for the separation between HER2 2-31 in situ hybridization (ISH)-positive cores (HER2 classical overexpression) and HER2 0-21 ISH-negative cores (HER2-low expression range). Conclusions.--Our QIA method can be beneficial to use as a reliable HER2 scoring tool for HER2 classical overexpression and HER2-low in BCs. It was found to be agnostic and provided same accuracy irrespective of IHC assay applied.
      pubtype: Academic Journal
      doctype:
        pictorial
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
    refInfo:
    holdings:
      @attributes:
        islocal: N