Related Experiment Video
Updated: Jul 6, 2026
08:28
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 the UK: further update to recommendations
R A Walker1, J M S Bartlett, M Dowsett
1Department of Cancer Studies and Molecular Medicine, University of Leicester, RKCSB, Leicester Royal Infirmary, Leicester, UK. raw14@le.ac.uk
Journal of Clinical Pathology
|April 3, 2008
Summary
Updated UK guidelines provide recommendations for accurate HER2 testing in all breast cancer patients. These guidelines ensure reliable results through standardized immunohistochemistry and in situ hybridisation methods.
Area of Science:
- Oncology
- Pathology
- Genetics
Background:
- The human epidermal growth factor receptor 2 (HER2) is a key biomarker in breast cancer treatment.
- Accurate HER2 testing is crucial for guiding targeted therapy decisions.
- Previous guidelines required updates to reflect advancements in testing methodologies.
Purpose of the Study:
- To provide updated recommendations for HER2 testing in breast cancer patients.
- To ensure accurate, reliable, and timely HER2 testing results.
- To standardize methodology, interpretation, and quality assurance for HER2 assays.
Main Methods:
- Recommends immunohistochemistry (IHC) as a primary testing method.
- Suggests in situ hybridisation (ISH) for equivocal IHC cases.
- Proposes frontline fluorescence in situ hybridisation (FISH) as an alternative, recommending a chromosome 17 probe.
Main Results:
- IHC is recommended, with ISH for clarification of equivocal results.
- Frontline FISH testing is an option for laboratories.
- Validation of chromogenic/silver ISH against FISH is advised.
- Participation in National External Quality Assurance schemes is mandatory.
Conclusions:
- Updated guidelines ensure consistent and accurate HER2 testing for all breast cancer patients.
- Standardized methodologies and quality assurance are essential for reliable HER2 status determination.
- These recommendations aim to improve patient outcomes through appropriate targeted therapy selection.
