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Updated: Aug 7, 2026
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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
HER2 testing in breast cancer: NCCN Task Force report and recommendations
Robert W Carlson1, Susan J Moench, M Elizabeth H Hammond
1Stanford Hospital and Clinics.
Summary
Accurate human epidermal growth factor receptor 2 (HER2) testing is crucial for breast cancer treatment decisions. This evaluation ensures reliable HER2 status assignment for both adjuvant and metastatic settings.
Area of Science:
- Oncology
- Pathology
- Genetics
Background:
- HER2 expression and gene amplification are key factors in breast cancer prognosis and treatment.
- Reliable laboratory methods are essential for accurate HER2 assessment.
Purpose of the Study:
- To evaluate HER2 as a prognostic and predictive factor in breast cancer.
- To assess the reliability of HER2 testing methodologies.
- To provide recommendations for HER2 test result interpretation.
Main Methods:
- Multidisciplinary expert task force convened for a 2-day meeting.
- Didactic presentations critically evaluating HER2 biology, epidemiology, and clinical trial data.
- Evidence-based consensus approach to formulate recommendations.
Main Results:
- Accurate HER2 status assignment is essential for clinical decision-making in both adjuvant and metastatic breast cancer.
- Formal validation and concordance testing are recommended for all HER2 testing laboratories.
- Immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) are reliable methods when quality control is in place.
Conclusions:
- HER2 status is critical for guiding breast cancer treatment strategies.
- Standardized testing and reporting are necessary for consistent patient care.
- Clear criteria for HER2-negative, HER2-positive, and borderline cases are established.
