ArticleBMC clinical pathology2013
Comparison of automated and manual FISH for evaluation of HER2 gene status on breast carcinoma core biopsies.
Article in BMC clinical pathology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed, 24 citations in OpenAlex.
- Evolving Concepts and Contemporary Management of Early-Stage Breast Cancer: An Evidence-Based Approach to Grey Zones from a Comprehensive Breast Unit Part 1: Locoregional Therapy, Pathology, Radiology.European journal of breast health · 2026Article
- Automated detection of the HER2 gene amplification status in Fluorescence in situ hybridization images for the diagnostics of cancer tissues.Scientific reports · 2019Article
- High-content, cell-by-cell assessment of HER2 overexpression and amplification: a tool for intratumoral heterogeneity detection in breast cancer.Laboratory investigation; a journal of technical methods and pathology · 2019Article
- Fluorescent in Situ Hybridization and Real-Time Quantitative Polymerase Chain Reaction to EvaluateIranian journal of pathology · 2017Article
- Fully automated fluorescent in situ hybridization (FISH) staining and digital analysis of HER2 in breast cancer: a validation study.PloS one · 2015Article
- Quantification of myocardial fibrosis by digital image analysis and interactive stereology.Diagnostic pathology · 2014Article
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Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPositive HER2 status identifies breast carcinomas that might respond to trastuzumab treatment. Manual HER2 fluorescent in situ hybridisation (FISH) is the most readily used method to detect HER2 gene amplification which defines positive HER2 status in addition to HER2 protein overexpression. Automation of HER2 FISH may improve HER2 gene testing. The aim of our study was to evaluate an automated HER2 FISH assay for assessing the HER2 genomic status.
methodsCore biopsies of 100 invasive breast carcinomas were analysed in parallel using the PathVysion™ HER-2 DNA Probe Kit and the Leica HER2 FISH System for BOND™. To assess inter-method agreement, concordance analysis was performed for various numerical and categorical HER2/CEP17 FISH parameters.
resultsCarcinomas with all HER2 immunohistochemical scores were included (0+: 20; 1+: 20; 2+: 30; 3+: 30). Using either HER2/CEP17 ratio >2.2 or ≥2.0 as criterion for HER2 amplification, high levels of concordance were observed between automated and manual FISH (concordance rate 96%, κ coefficient 0.92). High levels of inter-method agreement were also found for HER2 copy number, CEP17 copy number, HER2/CEP17 ratio, the percentage of carcinoma cells with HER2/CEP17 ratio >2.2, and the presence of HER2 genetic heterogeneity, HER2 clusters and CEP17 polyploidy.
conclusionsHER2 testing using automated FISH is feasible on breast carcinoma core biopsies. Automated HER2 FISH using the Leica HER2 FISH System for BOND is a practical and efficient alternative to manual HER2 FISH in evaluating the HER2 status of primary invasive breast carcinomas.
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