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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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