Speaker: Jeff Goldsmith
Description: At the end of the session, participants will be able to:
- Define analytic validation/verification in IHC and explain how “fit-for-purpose” thinking shapes what “acceptable performance” means for a given assay and intended clinical use
- Summarize the regulatory and practice expectations that require labs to validate laboratory-developed IHC assays and verify FDA-cleared IHC assays before reporting patient results
- Apply current guideline-based approaches to validation design, including appropriate comparator strategies and recommended challenge set sizes (e.g., minimum positive/negative cases; special considerations for predictive markers)
- Identify when separate validation is needed (e.g., alternate fixatives/cytology preparations)
- Describe future directions toward calibrators/standardization and the potential role of image analysis.