摘要: The HER2 gene is amplified and overexpressed in about 15%-20% of breast cancers. For every newly diagnosed cancer testing a standard routine procedure. This article focuses on number issues raised the context current cancer. It particularly points out arising recently published ASCO-CAP (American Society Clinical Oncology/College American Pathologists) guideline recommendations for clinical HER2. Despite significant correlation between status determination by immunohistochemistry (IHC) fluorescence situ hybridization (FISH), considerations laboratory testing, such as test accuracy, reproducibility precision well data, favor FISH methods over IHC assay status. Biological technical are also important practice. example, amplification directly linked to protein expression level cancer; however, not consistently analyzed formalin fixed tissues due variability fixation methods/times impact this antigenicity. significantly less dependent tissue artifacts. Hence, more reproducible both central peripheral laboratories than accurate measurement, being strongly correlated with responsiveness trastuzumab lapatinib treatment. Until other able ensure similar reproducibility, predictive value, recommended primary modality women who candidates HER2-targeted therapies.