Abstract
HER2 gene status is an important biological marker that determines both the prognosis and response to Trastuzumab in patients with breast cancers. Although FISH assay has long been used to determine HER2 gene copy number, DISH is gaining popularity since it can be assessed with a conventional microscope. Because the DISH test relies on an individual inspection, inter-observer variation might be an issue. In the current study, reproducibility in the assessment of HER2 DISH test was evaluated in 69 breast cancer samples with HER2 IHC score 2+ and 3+. Two independent investigators evaluated the digitally-captured images of DISH (10–20 images per case), taken at x600 magnification, without the knowledge of HER2 IHC status. The HER2/CEP17 ratio obtained from both observers were highly correlated (R = 0.883, p
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