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Updated: Jun 5, 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
Immunohistochemical detection of mutated epidermal growth factor receptors in pulmonary adenocarcinoma
Haruhiko Nakamura1, Atsushi Mochizuki, Takuo Shinmyo
1Department of Chest Surgery, St Marianna University School of Medicine, Kawasaki, Kanagawa, Japan. h-nakamura@marianna-u.ac.jp
Background:
Epidermal growth factor receptor (EGFR) mutational analysis has become essential in determining a therapeutic strategy for lung cancer. This study validated the reliability of recently generated rabbit monoclonal antibodies that recognise specific mutations of the EGFR protein.
Patients And Methods:
Pulmonary adenocarcinoma tissue from 20 previously genotyped specimens was prepared for immunohistochemical staining by two antibodies that recognise products of in-frame deletions in exon 19 (E746_A750del) and a point mutation that replaces leucine with arginine at codon 858 in exon 21 (L858R) of the EGFR gene.
Results:
The findings of EGFR-mutation-specific immunohistochemistry were concordant with the results of DNA analysis in 18 of 20 tested samples leading to 90% sensitivity and 100% specificity of the method.
Conclusion:
This immunohistochemical assay for products of representative EGFR gene mutations may be performed reliably using tissue specimens from resected pulmonary adenocarcinomas.
