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Comparative Study
. 2011 Jun;24(6):794-800.
doi: 10.1038/modpathol.2011.9. Epub 2011 Feb 11.

Dual-color silver-enhanced in situ hybridization for assessing HER2 gene amplification in breast cancer

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Comparative Study

Dual-color silver-enhanced in situ hybridization for assessing HER2 gene amplification in breast cancer

Young Wha Koh et al. Mod Pathol. 2011 Jun.
Free article

Abstract

Amplification of the human epidermal growth factor receptor 2 (HER2) gene occurs in 20-25% of breast cancers, and is recognized as a prognostic and predictive marker. HER2 gene amplification, evaluated as a change in protein expression or gene copy number, can be identified by a number of methods. Fluorescence in situ hybridization (FISH) is considered the gold standard for HER2 gene copy number determination; however, a number of impediments prevent its wider use in a clinical setting. The aims of our study were to compare dual-color silver-enhanced in situ hybridization (SISH) with single-color SISH and FISH on formalin-fixed, paraffin-embedded sections, and to validate its use as a routine method for assessing HER2 status in breast cancers. A total of 146 invasive breast carcinoma cases were assessed for HER2 gene amplification by FISH and dual-color SISH. Dual-color SISH and FISH results exhibited a concordance rate of 97% (κ=0.912). A comparison of the single-color SISH method with dual-color SISH showed that 142 of 146 cases were in agreement (97%, κ=0.930). Our results showed that dual-color SISH is a viable alternative to FISH that offers a number of advantages in a clinical setting.

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