The knowns and the unknowns in HER2 testing in breast cancer
The 2007 American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines for HER2 immunohistochemical and fluorescence in situ hybridization (FISH) testing in breast cancer address the potential impact of several “knowns” (eg, effect of fixative composition and fixation time).1,2 However, data continue to be generated that shed further light on the impact of “unknowns,” ie, selected preanalytic, analytic, and postanalytic (ie, interpretive) factors, on HER2 immunohistochemical testing.
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