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Related Experiment Video

Updated: Jun 25, 2026

Validated Immunochemical Assay for Comprehensive Determination of the Human Epidermal Growth Factor Receptor 2 Released from and Bound to Cells

Validated Immunochemical Assay for Comprehensive Determination of the Human Epidermal Growth Factor Receptor 2 Released from and Bound to Cells

Published on: May 9, 2025

Guidelines for human epidermal growth factor receptor 2 testing: biologic and methodologic considerations.

Guido Sauter¹, James Lee, John M S Bartlett

¹Department of Pathology and Norris Comprehensive Cancer Center, University of Southern California Keck School of Medicine, 1441 Eastlake Ave, Ste 5409, Los Angeles, CA 90033; press@usc.edu.

Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology

|February 11, 2009

Summary

Fluorescent in situ hybridization (FISH) is recommended over immunohistochemistry (IHC) for human epidermal growth factor receptor 2 (HER-2) testing in breast cancer. FISH offers superior accuracy, reproducibility, and predictive value for HER-2 targeted therapies.

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Area of Science:

Oncology
Pathology
Molecular Diagnostics

Background:

The American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) provides guidelines for human epidermal growth factor receptor 2 (HER-2) testing.
HER-2 status is crucial for breast cancer treatment decisions, particularly for HER-2-targeted therapies.

Purpose of the Study:

To systematically review and address issues within the ASCO-CAP guidelines for HER-2 testing.
To evaluate biologic and methodologic considerations for HER-2 assay interpretation.

Main Methods:

A review of existing data and ASCO-CAP guidelines by experienced investigators.
Comparative analysis of immunohistochemistry (IHC) and fluorescent in situ hybridization (FISH) for HER-2 testing.

Main Results:

While HER-2 status by IHC and FISH are correlated, FISH demonstrates superior accuracy, reproducibility, and precision.
FISH is less dependent on tissue fixation variability compared to IHC.
FISH shows a stronger correlation with responsiveness to HER-2 targeted therapies like trastuzumab and lapatinib.

Conclusions:

Fluorescent in situ hybridization (FISH) is favored over immunohistochemistry (IHC) for determining HER-2 status in breast cancer.
FISH is recommended as the primary HER-2 testing modality due to its superior test accuracy, reproducibility, and predictive value for targeted therapies.