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Related Experiment Videos

HER-2 testing in breast cancer using parallel tissue-based methods.

Hadi Yaziji1, Lynn C Goldstein, Todd S Barry

  • 1PhenoPath Laboratories, Seattle, Wash 98103, USA.

JAMA
|April 29, 2004
PubMed
Summary
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The Suitability of Repurposed, Legacy HER2 Immunohistochemistry Assays for the Detection of HER2 Low and Ultralow Expression: Current Limitations and Potential Considerations.

Applied immunohistochemistry & molecular morphology : AIMM·2025

Immunohistochemistry (IHC) is an efficient primary test for HER-2 oncogene in breast cancer. Fluorescence in situ hybridization (FISH) testing is recommended only for indeterminate (2+) IHC results, ensuring cost-effectiveness and accuracy.

Area of Science:

  • Oncology
  • Molecular Diagnostics
  • Breast Cancer Research

Background:

  • The HER-2 oncogene is a crucial prognostic and predictive factor in breast cancer.
  • Fluorescence in situ hybridization (FISH) and immunohistochemistry (IHC) are methods for HER-2 testing, with ongoing debate on their comparative accuracy for predicting trastuzumab response.
  • Critical evaluation of FISH for screening purposes is needed.

Purpose of the Study:

  • To assess the correlation between FISH and IHC results for HER-2/neu gene status.
  • To determine HER-2 gene status in tumors with indeterminate (2+) IHC results.
  • To confirm gene amplification in tumors with positive (3+) and negative (0 or 1+) IHC results.

Main Methods:

  • A quality control and assurance program evaluated HER-2 testing by FISH on 2963 breast cancer specimens from 135 institutions.

Related Experiment Videos

  • FISH testing was performed in parallel with IHC on all specimens.
  • IHC sensitivity, specificity, and predictive values were calculated using FISH as the standard.

    • Main Results:

    • IHC demonstrated high accuracy: positive predictive value of 91.6% for 3+ scores and negative predictive value of 97.2% for 0 or 1+ scores.
    • IHC sensitivity (92.6%) and specificity (98.8%) were robust.
    • FISH exhibited a higher failure rate (5% vs 0.08%), significantly higher reagent costs ($140 vs $10), and longer testing and interpretation times compared to IHC.

    Conclusions:

    • An efficient HER-2 testing algorithm utilizes IHC as the primary method.
    • FISH testing should be reserved for cases with indeterminate (2+) IHC results.
    • Robust quality control and assurance programs are essential for reliable HER-2 testing strategies.