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Peer-Reviewed Publication
Lab Invest2026;106(8):106136.May 19, 2026Journal Article

Immunohistochemical Assay Variability and Human Epidermal Growth Factor Receptor 2 (HER2)-Low Breast Cancer Detection: A Laboratory Comparison in the Netherlands.

Zeynep E Kain1, Emma Schuurman2, Ximena Baez-Navarro3, Henrik Høeg4, Prasanth Kanneganti5, Nils 't Hart2, Carolien H M van Deurzen3
1Department of Pathology, Erasmus University Medical Center, Rotterdam, the Netherlands. Electronic address: z.kain@erasmusmc.nl.
2Department of Pathology, Isala, Zwolle, the Netherlands.
3Department of Pathology, Erasmus University Medical Center, Rotterdam, the Netherlands.
4Visiopharm A/S, Hørsholm, Denmark.
5Boston Cell Standards Inc, Boston, Massachusetts.

Abstract

PURPOSE: HER2-low breast cancer has gained clinical relevance owing to the efficacy of trastuzumab deruxtecan. However, variability in detecting low HER2 expression may affect patient eligibility. This nationwide study in the Netherlands evaluated the variability in HER2 immunohistochemistry (IHC) assays at low expression levels and compared this with the reported HER2-low rates across pathology l…

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