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CONTEXT: Practicing pathologists often encounter controversial clinical issues and nonstandardized laboratory approaches to the evolving science of predictive/prognostic tumor marker assays. This dilemma becomes especially acute when the assay is the sole determinant for selection of a specific therapy. OBJECTIVES: To summarize the areas of practical agreement and identify opportunities for improvement in Her-2/neu testing of breast cancer. DESIGN: The College of American Pathologists created a new comprehensive education model, called Strategic Science, with expert speakers integrating new and evolving basic, clinical, and scientific issues of Her-2/neu testing with aspects of laboratory management. SETTING: Symposium held May 4 and 5, 2002, in Rosemont, Ill. PARTICIPANTS: Ten speakers and more than 100 attendees. RESULTS: Components addressed were new technology assessment, practice guidelines, quality assurance, regulatory compliance, risk and liability, billing and coding, cost analysis, consultation, information management, and results reporting. CONCLUSIONS: This Strategic Science symposium derived areas of practical agreement, defined the current state-of-the-art, and identified areas for improvement in Her-2/neu testing.
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Zarbo et al. (2003) studied this question.
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