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.