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Related Experiment Video

Updated: Oct 27, 2025

Building Up a High-throughput Screening Platform to Assess the Heterogeneity of HER2 Gene Amplification in Breast Cancers
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HER2 Testing: Insights From Pathologists' Perspective on Technically Challenging HER2 FISH Cases.

Erin V Grimm1, Kimberly H Allison2, David G Hicks3

  • 1Allina Health Laboratories/Hospital Pathology Associates.

Applied Immunohistochemistry & Molecular Morphology : AIMM
|July 20, 2021
PubMed
Summary
This summary is machine-generated.

This study analyzed challenging HER2 fluorescence in situ hybridization (FISH) cases, revealing interpretation discrepancies in low positive HER2 cases and highlighting the need for clear strategies in diagnosing difficult breast cancer cases.

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Area of Science:

  • Oncology
  • Pathology
  • Genetics

Background:

  • Established guidelines exist for HER2 interpretation in breast cancer.
  • Certain cases present diagnostic challenges for HER2 assessment.

Purpose of the Study:

  • To analyze challenging HER2 fluorescence in situ hybridization (FISH) cases.
  • To identify interpretation strategies for difficult HER2 cases.

Main Methods:

  • Ten challenging HER2 FISH cases were analyzed by six high-volume laboratories.
  • Cases included discordant IHC/FISH results, high intratumoral variability, amplified clones, and clumped HER2 signals.

Main Results:

  • 100% concordance was achieved in 4/10 cases.
  • Low positive HER2 cases (<6 average HER2 copies/cell) showed discordance between laboratories and methodologies.
  • High intratumoral variability cases had 100% concordance in 3/4 instances.

Conclusions:

  • Specific interpretation strategies are offered for difficult HER2 FISH cases.
  • Communication strategies for discussing unusual HER2 results with clinical teams are highlighted.