Instant-quality fluorescence in-situ hybridization as a new tool for HER2 testing in breast cancer: a comparative study.

作者: Camille Franchet , Thomas Filleron , Anne Cayre , Eveline Mounié , Frédérique Penault-Llorca

DOI: 10.1111/HIS.12247

关键词: Internal medicineBreast cancerPathologyFish <Actinopterygii>BiologyStatistical analysisIn situ hybridizationPredictive markerTissue microarrayOncologyFluorescence in situ hybridization

摘要: Aims HER2 instant-quality fluorescence in-situ hybridization (IQFISH) is a new (FISH) assay developed with non-toxic buffer that reduces the time to 1–2 h, enabling turnaround of 3 h 30 min from dewax counting. The aim this study was compare assessment HER2 status using IQFISH and standard FISH. Methods results We selected 160 breast cancer samples according their as determined by immunohistochemistry (IHC) in retrospective multicentre cohort (40 cases each scoring category, i.e. 0/1+/2+/3+). Each participating site (n = 5) constructed its tissue microarray (TMA) 32 archival sent it central (site 1). IHC, FISH were performed blindly at 1. provided excellent quality signals without any background staining, thus allowing reading conditions even on TMA. Statistical analysis showed almost perfect agreement between (99.3%, κ = 0.98). only discordant case an equivocal one HER2/CEP17 ratio near ASCO/CAP cut-off. Conclusions The highly concordant data support useful alternative FISH, reliable status. Use method could lead reporting HER oncologist within day.

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