A New Rabbit Monoclonal Antibody (4B5) for the Immunohistochemical (IHC) Determination of the HER2 Status in Breast Cancer: Comparison With CB11, Fluorescence In Situ Hybridization (FISH), and Interlaboratory Reproducibility

Abstract excerpt

The 2 methodologies in current clinical use to assess HER2 status in breast cancer are: fluorescence in situ hybridization (FISH) (gene amplification) and immunohistochemistry (protein over-expression). A consistent finding has been that 3% to 15% of breast cancers over-express HER2 protein without evidence for gene amplification. Accurate determination of the HER2 status has implications for selecting patients...

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