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Dako's HercepTest Data Good In Extremes, Lacking In Middle

This article was originally published in The Gray Sheet

Executive Summary

Inter-laboratory reproducability results using Dako's HercepTest immunohistochemical anti-HER2 assay with automated staining techniques showed an 82-90% agreement between labs determining negative or positive overexpression of HER2 according to clinical data presented to FDA's Hematology and Pathology/Immunology Devices Panels Sept. 4.
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