PMID- 28110280 OWN - NLM STAT- MEDLINE DCOM- 20170414 LR - 20220316 IS - 1943-7722 (Electronic) IS - 0002-9173 (Linking) VI - 147 IP - 1 DP - 2017 Jan 1 TI - HER2 Gene Protein Assay Is Useful to Determine HER2 Status and Evaluate HER2 Heterogeneity in HER2 Equivocal Breast Cancer. PG - 89-95 LID - 10.1093/ajcp/aqw211 [doi] AB - OBJECTIVES: Approximately 15% of breast cancers show equivocal human epidermal growth factor receptor 2 (HER2) results on HER2 immunohistochemistry (IHC) and are reflexed for fluorescence in situ hybridization (FISH). However, some cases remain equivocal. In this study, we evaluated these double-equivocal cases by using a novel gene protein assay (GPA), which can simultaneously assess HER2 gene copy number and protein on a single slide using bright-field microscopy. METHODS: GPA was performed on 42 HER2 IHC and FISH double-equivocal cases. RESULTS: GPA was negative for amplification in 28 cases, equivocal in three cases, and positive in 11 cases. The GPA results showed excellent concordance with either repeat FISH using a chromosome 17 centromere probe or FISH using an alternative probe. Furthermore, HER2 heterogeneity was identified in three of 11 GPA-positive cases. CONCLUSIONS: HER2 GPA performs accurately and is very useful to determine HER2 status in HER2 IHC and FISH double-equivocal breast cancer cases and identify HER2 heterogeneity. CI - (c) American Society for Clinical Pathology, 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com FAU - Hou, Yanjun AU - Hou Y AD - From the Department of Pathology, Wexner Medical Center at The Ohio State University, Columbus. FAU - Nitta, Hiroaki AU - Nitta H AD - Ventana Medical Systems, Tucson, AZ. FAU - Li, Zaibo AU - Li Z AD - From the Department of Pathology, Wexner Medical Center at The Ohio State University, Columbus. LA - eng PT - Journal Article PL - England TA - Am J Clin Pathol JT - American journal of clinical pathology JID - 0370470 RN - 0 (Biomarkers, Tumor) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Biomarkers, Tumor/*analysis/genetics MH - Breast Neoplasms/*genetics MH - Female MH - Gene Amplification MH - Gene Dosage MH - Genes, erbB-2/genetics MH - Humans MH - Immunohistochemistry/*methods MH - In Situ Hybridization/*methods MH - Receptor, ErbB-2/*genetics OTO - NOTNLM OT - Breast carcinoma OT - Fluorescence in situ hybridization OT - HER2 gene protein assay OT - HER2 heterogeneity OT - Immunohistochemistry EDAT- 2017/01/23 06:00 MHDA- 2017/04/15 06:00 CRDT- 2017/01/23 06:00 PHST- 2017/01/23 06:00 [pubmed] PHST- 2017/04/15 06:00 [medline] PHST- 2017/01/23 06:00 [entrez] AID - aqw211 [pii] AID - 10.1093/ajcp/aqw211 [doi] PST - ppublish SO - Am J Clin Pathol. 2017 Jan 1;147(1):89-95. doi: 10.1093/ajcp/aqw211.