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HER-2 Testing in Breast Cancer
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To the Editor: Dr Yaziji and colleagues1 present a cogent argument for a cost-effective algorithmic approach to HER-2 testing of breast carcinoma based on a carefully conducted and executed study of 2963 samples. We would like to point out several issues not directly addressed in the article or the accompanying editorial.2
Three clinical assays have been approved by the Food and Drug Administration (FDA) for determination of HER-2 status of breast cancer: HercepTest (DakoCytomation, Glostrup, Denmark), Pathway (Ventana Medical Systems Inc, Tucson, Ariz), and PathVysion (Abbott Vysis, Abbott Park, Ill). The first 2 are immunohistochemistry (IHC) assays and PathVysion is a fluorescence in situ hybridization (FISH) assay. Standardized scoring criteria have also been specified for each assay. The methods described by Yaziji et al did not use the first 2 FDA-approved IHC assays; rather, the DakoCytomation polyclonal antibody A0485 was used for IHC staining, not the approved HercepTest. Furthermore, . . . [Full Text of this Article]
Raymond R. Tubbs, DO
tubbsr@ccf.org
Department of Clinical Pathology
David G. Hicks, MD
Department of Anatomic Pathology
The Cleveland Clinic Foundation
Cleveland, Ohio
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