Quantitative comparison of immunohistochemical HER2-low detection in an interlaboratory study.
Maaike Anna HempeniusMaran A EenkhoornHenrik HøegDavid J DabbsBert Van der VegtSeshi R SompuramNils A 't HartPublished in: Histopathology (2024)
As assays were validated for detecting HER2-amplified tumours, not all assays and antibodies proved suitable for HER2-low detection. Some tests showed distinct expression in the negative cell line. Dynamic range cell line controls and quantitative analysis using calibrators demonstrated more interlaboratory variability than commonly appreciated. Revalidation of HER2 tests by laboratories is needed to ensure clinical applicable HER2-low assays.