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Evolution of Biomarker Validation


Most recently, an international team of experts from the International Society for Immunohistochemistry and Molecular Morphology (ISIMM) as well as the International Network for Quality in Pathology (IQN Path) developed new concepts and a new framework for biomarker validation in immunohistochemistry (IHC). Validation is ‘‘confirmation, through the provision of objective evidence, that requirements for a specific intended use or application have been fulfilled’’ (ISO 9000).“Intended use” or “intended application” are synonymous with “purpose” meaning that validation will result in a test that is fit-for-purpose. Provision of “objective evidence” is fulfilled by collecting evidence that relevant test performance characteristics have been identified and assessed. Validation provides a “high degree of assurance” that these needs will be met. This presentation will explore how these three components of validation (intended use, objective evidence, and high degree of assurance) can be incorporated into the validation of biomarkers for in-situ cell-based assays such as IHC.

Learning Objectives:

  1. Overview of terminology and definitions relevant to biomarker validation for in situ, cell-based assays.
  2. Describe components and processes for IHC biomarker validation.
  3. Describe tools required for biomarker validation.

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