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Updated: Apr 7, 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
Epidermal growth factor receptor immunohistochemistry: new opportunities in metastatic colorectal cancer
Ryan A Hutchinson1,2, Richard A Adams3, Darragh G McArt4
1Centre for Cancer Research and Cell Biology, Queen's University Belfast, 97 Lisburn Road, Belfast, BT9 7AE, Northern Ireland, UK. ryan.hutchinson@unimelb.edu.au.
Abstract:
The treatment of cancer is becoming more precise, targeting specific oncogenic drivers with targeted molecular therapies. The epidermal growth factor receptor has been found to be over-expressed in a multitude of solid tumours. Immunohistochemistry is widely used in the fields of diagnostic and personalised medicine to localise and visualise disease specific proteins. To date the clinical utility of epidermal growth factor receptor immunohistochemistry in determining monoclonal antibody efficacy has remained somewhat inconclusive. The lack of an agreed reproducible scoring criteria for epidermal growth factor receptor immunohistochemistry has, in various clinical trials yielded conflicting results as to the use of epidermal growth factor receptor immunohistochemistry assay as a companion diagnostic. This has resulted in this test being removed from the licence for the drug panitumumab and not performed in clinical practice for cetuximab. In this review we explore the reasons behind this with a particular emphasis on colorectal cancer, and to suggest a way of resolving the situation through improving the precision of epidermal growth factor receptor immunohistochemistry with quantitative image analysis of digitised images complemented with companion molecular morphological techniques such as in situ hybridisation and section based gene mutation analysis.
Insights
Improving epidermal growth factor receptor (EGFR) immunohistochemistry precision is crucial for targeted cancer therapy. Quantitative image analysis and molecular techniques can resolve conflicting clinical trial results for EGFR assays.
Area of Science:
- Oncology
- Molecular diagnostics
- Personalised medicine
Background:
- Epidermal growth factor receptor (EGFR) is over-expressed in many solid tumors, making it a target for cancer therapies.
- Immunohistochemistry (IHC) is a key diagnostic tool for visualizing disease-specific proteins.
- The clinical utility of EGFR IHC for predicting monoclonal antibody efficacy remains inconclusive due to inconsistent scoring criteria.
Purpose of the Study:
- To review the challenges and conflicting results associated with EGFR IHC in clinical trials, particularly for colorectal cancer.
- To propose a solution for improving the precision and reproducibility of EGFR IHC assays.
- To enhance the use of EGFR IHC as a companion diagnostic for targeted cancer therapies.
Main Methods:
- Review of existing clinical trial data and literature on EGFR IHC.
- Analysis of the reasons for conflicting results and lack of standardized scoring criteria.
- Proposal of integrating quantitative image analysis with molecular morphological techniques (e.g., in situ hybridization, gene mutation analysis).
Main Results:
- Lack of standardized scoring criteria for EGFR IHC has led to inconsistent results in clinical trials.
- This inconsistency has impacted the use of EGFR IHC as a companion diagnostic for drugs like panitumumab and cetuximab.
- Quantitative image analysis and molecular techniques offer a path to more precise and reproducible EGFR assessment.
Conclusions:
- Standardization of EGFR IHC scoring is essential for its reliable use in clinical practice.
- Quantitative image analysis combined with molecular methods can improve the precision of EGFR IHC.
- Enhanced EGFR IHC assays can better guide targeted cancer therapy and improve patient outcomes.
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