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Updated: Aug 18, 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
[HER2 testing for breast cancer. Swedish laboratories can now offer a quality assured analysis of growth factor]
Monica Haglund1, Gunilla Chebil, Leif Johansson
1Universitetssjukhuset MAS, Malmö. monica.haglund@skane.se
Abstract:
Between 20 and 30 per cent of all breast cancers show an overexpression of the growth factor HER2 and this implies a worse prognosis. Metastasising breast cancer that overexpress HER2 can effectively be treated with trastuzumab (Herceptin). In order to determine whether this treatment is indicated, HER2 expression must be quantified with immunohistochemical or molecular biological methods. Several factors may influence the laboratory analysis of HER2, such as choice of antibodies and probes, the reliability of the test performance itself and the performance of the pathologist(s) interpreting the test. National guidelines for HER2 testing have been published in several countries. In this article a series of quality assurance projects leading to the formulation of Swedish guidelines for HER2 testing is described. These projects have demonstrated that several Swedish pathology laboratories can reliably perform and interpret analysis of HER2 status today.
Insights
Human epidermal growth factor receptor 2 (HER2) testing is crucial for breast cancer treatment. Quality assurance projects in Sweden have confirmed reliable HER2 analysis in pathology labs.
Area of Science:
- Oncology
- Pathology
- Molecular Biology
Context:
- HER2 overexpression occurs in 20-30% of breast cancers, indicating a poorer prognosis.
- Trastuzumab (Herceptin) is an effective treatment for HER2-positive metastatic breast cancer.
- Accurate HER2 quantification is essential for determining treatment eligibility.
Purpose:
- To describe quality assurance projects for HER2 testing.
- To establish Swedish national guidelines for HER2 testing.
- To ensure reliable HER2 analysis in Swedish pathology laboratories.
Summary:
- The study details quality assurance initiatives that led to the development of Swedish guidelines for HER2 testing.
- These projects evaluated factors influencing HER2 analysis, including antibody selection, test performance, and pathologist interpretation.
- The findings indicate that Swedish pathology laboratories can now reliably perform and interpret HER2 status analyses.
Impact:
- Improved accuracy in HER2 testing for breast cancer patients in Sweden.
- Standardization of HER2 testing procedures across Swedish pathology laboratories.
- Enhanced clinical decision-making for HER2-targeted therapies, potentially improving patient outcomes.
