PMID- 32317514 OWN - NLM STAT- MEDLINE DCOM- 20210127 LR - 20220414 IS - 0974-5130 (Electronic) IS - 0377-4929 (Linking) VI - 63 IP - 2 DP - 2020 Apr-Jun TI - Dual-color dual-hapten in situ hybridization (D-DISH) - Comparison with fluorescence in situ hybridization (FISH) for HER2/neu testing in breast cancer. PG - 194-199 LID - 10.4103/IJPM.IJPM_861_19 [doi] AB - CONTEXT: HER2/neu testing in breast cancer is a mandate due to availability of trastuzumab, a monoclonal antibody targeted against this biomarker. Dual-color dual-hapten in situ hybridization (D-DISH) is a new test for assessment of HER2/neu gene overexpression on light microscopy. AIMS: This was a validation study for D-DISH in our laboratory and was conducted to study the concordance between fluorescence in situ hybridization (FISH) and D-DISH for HER2/neu testing in breast cancer. MATERIALS AND METHODS: In all, 150 cases of invasive breast carcinoma requested for FISH analysis were selected. Immunohistochemistry by Ventana PATHWAY anti-HER2/neu (4B5) antibody, FISH by ZytoLight SPEC ERBB2/CEN17 Dual Color Probe, and D-DISH using the Ventana INFORM HER2 Dual ISH DNA Probe Cocktail Assay was carried out. STATISTICAL ANALYSIS: Cohen's kappa coefficient was used to calculate concordance between FISH and D-DISH assays. The ratios and average number of signals were compared with Lin's concordance correlation coefficient. RESULTS: About 93.1% of the cases showed concordance between FISH and D-DISH results. Cohen's kappa correlation coefficient was 0.836, indicating almost perfect level of agreement. Lin's concordance correlation coefficient (rhoc) showed moderate strength of agreement for HER2/chromosome 17 ratios between FISH and D-DISH assays (rhoc 0.9452). As per the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) 2018 updated guidelines, four of the cases that were nonamplified on FISH showed low-level amplification on D-DISH due to counting errors caused by faint signals or background dust. Genomic heterogeneity and larger red chromosome 17 signals on D-DISH led to discordance of the six cases amplified by FISH. D-DISH failure rate was 3.33%. CONCLUSION: Overall, D-DISH showed good concordance with FISH but needs expertise for reporting. FAU - Gajaria, Pooja K AU - Gajaria PK AD - Department of Pathology, Tata Memorial Hospital, Mumbai, Maharashtra, India. FAU - Tambe, Sonali AU - Tambe S AD - Department of Pathology, Tata Memorial Hospital, Mumbai, Maharashtra, India. FAU - Pai, Trupti AU - Pai T AD - Department of Pathology, Tata Memorial Hospital, Mumbai, Maharashtra, India. FAU - Patil, Asawari AU - Patil A AD - Department of Pathology, Tata Memorial Hospital, Mumbai, Maharashtra, India. FAU - Desai, Sangeeta B AU - Desai SB AD - Department of Pathology, Tata Memorial Hospital, Mumbai, Maharashtra, India. FAU - Shet, Tanuja M AU - Shet TM AD - Department of Pathology, Tata Memorial Hospital, Mumbai, Maharashtra, India. LA - eng PT - Comparative Study PT - Journal Article PT - Validation Study PL - India TA - Indian J Pathol Microbiol JT - Indian journal of pathology & microbiology JID - 7605904 RN - 0 (Haptens) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Breast Neoplasms/*diagnosis/pathology MH - *Color MH - Female MH - Haptens MH - Humans MH - Immunohistochemistry MH - In Situ Hybridization/*methods MH - *In Situ Hybridization, Fluorescence MH - Paraffin Embedding MH - Receptor, ErbB-2/*genetics OTO - NOTNLM OT - Concordance OT - HER2 OT - dual-color dual-hapten in situ hybridization OT - fluorescence in situ hybridization OT - invasive breast carcinoma OT - validation EDAT- 2020/04/23 06:00 MHDA- 2021/01/28 06:00 CRDT- 2020/04/23 06:00 PHST- 2020/04/23 06:00 [entrez] PHST- 2020/04/23 06:00 [pubmed] PHST- 2021/01/28 06:00 [medline] AID - IndianJPatholMicrobiol_2020_63_2_194_282719 [pii] AID - 10.4103/IJPM.IJPM_861_19 [doi] PST - ppublish SO - Indian J Pathol Microbiol. 2020 Apr-Jun;63(2):194-199. doi: 10.4103/IJPM.IJPM_861_19.