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Updated: Jul 25, 2025

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
Exploration of HER2 (ERBB2) immunohistochemistry in non-small cell lung cancer: correlation with ERBB2 mutational
Anthony B Cardillo1, Sierra Kovar1, Nitin Roper2
1Department of Pathology and Laboratory Medicine, University of Rochester, Rochester, NY.
Abstract:
ERBB2 (HER2) is a gene in humans that encodes the ERBB2 protein, a member of the epidermal growth factor receptor family. Non-small cell lung carcinomas do not commonly harbour ERBB2 mutations, with clinical trials conducted to assess for targeted response and progression-free survival. We retrieved cases of lung adenocarcinoma with next-generation sequencing proven ERBB2 point mutations (n=8) or amplifications (n=11) and assessed the concordance of commercially available ERBB2 (HER2) immunohistochemical antibodies with the next-generation sequencing result. At present, no commercially available ERBB2 clone can accurately detect ERBB2 mutations consistently in non-small cell lung carcinoma specimens, but amplifications can be detected with reasonable diagnostic accuracy.

