HER2 Gene Protein Assay Is Useful to Determine HER2 Status and Evaluate HER2 Heterogeneity in HER2 Equivocal Breast Cancer.

Abstract:

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.

journal_name

Am J Clin Pathol

authors

Hou Y,Nitta H,Li Z

doi

10.1093/ajcp/aqw211

subject

Has Abstract

pub_date

2017-01-01 00:00:00

pages

89-95

issue

1

eissn

0002-9173

issn

1943-7722

pii

aqw211

journal_volume

147

pub_type

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