Elsevier, Annals of Diagnostic Pathology, 4(19), p. 203-210, 2015
DOI: 10.1016/j.anndiagpath.2015.04.002
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Human Epidermal Growth Factor Receptor 2 (HER2) immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) are widely used semi quantitative assays for selecting breast cancer patients for HER2 antibody therapy. However, both techniques have been shown to have disadvantages. Our aim was to test a recent automated technique of combined IHC and bright field dual in situ hybridization (DISH) - Gene Protein Detection Platform (GPDP) in breast cancer HER2 protein, gene and chromosome 17-centromere (CEP17) status evaluations, comparing the results in accordance to the ASCO/CAP recommendations for HER2 testing in Breast Cancer from both 2007 and 2013. The GPDP technique performance was evaluated on 52 consecutive whole-slide invasive breast cancer cases with HER2 IHC 2/3+ scoring results. Applying in turns the ASCO/CAP recommendations for HER2 testing in Breast Cancer from 2007 and 2013 to both FISH and GPDP Dual ISH assays, the HER2 gene amplification results showed 100% concordance among amplified/non-amplified cases, but there was a shift in 4 cases towards positive from equivocal results, and towards equivocal from negative results. This might be related to the emphasis on the average HER2 copy number in the 2013 criteria. HER2 expression by IVD market IHC kit (Pathway) has a strong correlation with GPDP HER2 protein, including a full concordance for all cases scored as 3+, and a reduction from 2+ to 1+ in 7 cases corresponding to non-amplified cases. GPDP HER2 protein "solo" could have spared the need for 7 FISH studies. Additionally, the platform offered advantages on interpretation reassurance including selecting areas for counting gene signals paralleled with protein IHC expression, on heterogeneity detection, interpretation time, technical time and tissue expense.