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Updated: Aug 22, 2026
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
Testing for HER2 in breast cancer
Abstract:
HER2 is a paradigm of a molecular target whose appropriate assessment is pivotal in the targeting of novel therapies for breast cancer, notably including Herceptin/Trastuzumab. Determining the correct levels requires immunohistochemical and molecular biological skills that are reproducible and measurable, coupled with a knowledge of the appropriate morphological and pathobiological context. Attaining these goals is not easy and laboratories testing for HER2 should maintain a high level of throughput of tests and engage in a recognized external quality assurance scheme. Fluorescence in-situ hybridization testing remains a particular challenge and there is a range of testing strategies. This testing forms the model for the identification of other novel molecular targets. In the future rapid throughput techniques such as real-time quantitative polymerase chain reaction (rqPCR), tissue microarrays or both should bring significant economies of cost and scale.
Insights
Accurate human epidermal growth factor receptor 2 (HER2) testing is crucial for effective breast cancer treatment with targeted therapies like Trastuzumab. Laboratories must ensure high throughput and quality assurance for reliable HER2 assessment.
Area of Science:
- Oncology
- Molecular Biology
- Pathology
Background:
- Human epidermal growth factor receptor 2 (HER2) is a key molecular target in breast cancer therapy.
- Targeted therapies like Trastuzumab (Herceptin) efficacy relies on precise HER2 assessment.
Purpose of the Study:
- To highlight the importance of accurate HER2 assessment in breast cancer treatment.
- To discuss the challenges and strategies for reliable HER2 testing in laboratories.
Main Methods:
- Immunohistochemistry and molecular biological techniques are employed for HER2 determination.
- External quality assurance schemes are essential for validating laboratory performance.
- Fluorescence in-situ hybridization (FISH) is a critical but challenging testing method.
Main Results:
- Reproducible and measurable HER2 assessment requires specialized skills and contextual knowledge.
- High test throughput and participation in quality assurance programs are vital for laboratories.
- Various testing strategies exist for HER2, with FISH presenting specific challenges.
Conclusions:
- Accurate HER2 testing is fundamental for guiding breast cancer targeted therapies.
- Continuous quality improvement and adherence to established protocols are necessary.
- Future advancements in rapid techniques like real-time quantitative polymerase chain reaction (rqPCR) and tissue microarrays promise cost and scale efficiencies.
