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Updated: May 21, 2026
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Building Up a High-throughput Screening Platform to Assess the Heterogeneity of HER2 Gene Amplification in Breast Cancers
Published on: December 5, 2017
Determining sensitivity and specificity of HER2 testing in breast cancer using a tissue micro-array approach
Tim J A Dekker1, Susan Ter Borg, Gerrit K J Hooijer
1Department of Pathology, Academic Medical Center, Meibergdreef 9, Amsterdam, 1100 DD, The Netherlands.
Breast Cancer Research : BCR
|June 15, 2012
Summary
Retesting breast cancer HER2 status on tissue micro-arrays (TMAs) is feasible and accurate for quality control. This method identified fewer false-positive human epidermal growth factor receptor 2 (HER2) results than previously reported.
Area of Science:
- Oncology
- Pathology
- Biomarker Testing
Background:
- Human epidermal growth factor receptor 2 (HER2) overexpression in breast cancer indicates poor prognosis and predicts response to HER2-targeting therapies.
- Inaccurate HER2 testing, with false-positive rates up to 20%, necessitates improved standardization through external quality control.
Purpose of the Study:
- To assess the feasibility and reliability of retesting HER2 status in a large cohort of invasive breast carcinomas using tissue micro-arrays (TMAs) as part of a quality control initiative.
- To compare the accuracy of different HER2 testing methods, including immunohistochemistry (IHC) and in situ hybridization (ISH), on TMAs against local testing results.
Main Methods:
- Investigated 1,210 invasive breast carcinomas using HER2 detecting antibodies (SP3, 4B5) and silver in situ hybridization (SISH) on TMAs.
- Compared TMA retesting results with local HER2 test results for each tumor.
- Further investigated discordant cases by analyzing whole tumor sections.
Main Results:
- Achieved 98.0% concordance between local HER2 test results and TMA retesting.
- Identified 2.0% discordant results, including 1.3% false-positive and 0.7% false-negative HER2 IHC results.
- Demonstrated that SP3, 4B5, and mono-color SISH on TMAs are reliable for HER2 retesting.
Conclusions:
- Retesting large volumes of HER2-classified breast carcinomas on TMAs is a feasible and reliable quality control method.
- The combination of TMA staining with full-sized slide analysis for discordant cases ensures accurate HER2 status determination.
- This quality control approach yielded a lower frequency of false-positive HER2 results than previously reported, enhancing testing standardization.
