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Related Experiment Video

Updated: May 31, 2026

Building Up a High-throughput Screening Platform to Assess the Heterogeneity of HER2 Gene Amplification in Breast Cancers
11:34

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Trainable immunohistochemical HER2/neu image analysis: a multisite performance study using 260 breast tissue

Aziza Nassar1, Cynthia Cohen, Sally S Agersborg

  • 1Department of Pathology and Laboratory Medicine, Emory University School of Medicine, Atlanta, Georgia, USA. nassar.aziza@mayo.edu

Archives of Pathology & Laboratory Medicine
|July 8, 2011
PubMed
Summary
This summary is machine-generated.

A new trainable immunohistochemistry (IHC) HER2 Image Analysis (IA) system demonstrated substantial equivalence to manual microscopy for HER2/neu scoring. This automated image analysis significantly improved interpathologist agreement across multiple clinical sites.

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Area of Science:

  • Oncology
  • Pathology
  • Medical Imaging

Background:

  • Aperio Technologies developed a trainable immunohistochemistry (IHC) HER2 Image Analysis (IA) system.
  • This system allows adjustable intensity thresholds for HER2/neu scoring, adapting to various reagent staining characteristics.

Purpose of the Study:

  • To compare the performance of the trainable IHC HER2 IA system against conventional manual microscopy (MM).
  • The study aimed to evaluate the system's consistency across different reagents and multiple clinical sites.

Main Methods:

  • A multisite study involved 260 breast cancer specimens stained with Dako's HercepTest or Ventana's PATHWAY HER-2/neu.
  • Three pathologists performed blinded readings of glass slides via MM and subsequently analyzed scanned images using the IHC HER2 IA system.
  • Interpathologist agreement was assessed using kappa (κ) statistics for HER2/neu scoring (0, 1+, 2+, 3+).

Main Results:

  • The IHC HER2 IA system demonstrated higher kappa values, indicating better agreement, compared to MM across all three clinical sites.
  • Kappa values for IA ranged from 0.726 to 0.947, while MM ranged from 0.463 to 0.864.
  • The IA system showed substantial equivalence to MM, with comparative kappa values ranging from 0.497 to 0.892.

Conclusions:

  • Aperio's trainable IHC HER2 IA system is substantially equivalent to manual microscopy for HER2/neu scoring using Dako and Ventana reagents.
  • The image analysis system notably enhanced interpathologist agreement in HER2/neu scoring across diverse clinical settings.
  • This technology offers a promising tool for standardized and reproducible HER2 testing in breast cancer diagnostics.