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Recommendations on biomarker assay validation (BAV) in tissues by GCC
Moucun Yuan1, Aihua Liu2, Bin Xu3
1PPD, part of Thermo Fisher Scientific, Richmond, VA, USA.
Bioanalysis
|April 18, 2025
Summary
This white paper provides guidance on validating biomarker analysis in tissues, essential for understanding disease and meeting regulatory needs. It shares recommendations from GCC forums on technical and regulatory aspects of tissue biomarker bioanalysis.
Area of Science:
- Biomarker analysis
- Pathology
- Tissue-based assays
Background:
- Biomarker analysis offers critical insights into physiological processes and disease states.
- Evaluating the spatial distribution of biomarkers in tissues is increasingly important.
- Regulatory and sponsor requirements necessitate robust validation strategies.
Purpose of the Study:
- To disseminate survey results from the 16th & 17th GCC Closed Forums.
- To provide recommendations on technical and regulatory considerations for tissue biomarker bioanalysis.
- To establish guidance for validation approaches and parameter evaluation.
Main Methods:
- Survey dissemination
- GCC member recommendations
- Technical and regulatory review
Main Results:
- Key findings from GCC Closed Forums on tissue biomarker bioanalysis.
- Consensus recommendations from GCC members.
- Identified critical parameters for validation.
Conclusions:
- Standardized guidance is crucial for reliable tissue biomarker bioanalysis.
- Addressing technical and regulatory challenges ensures data integrity.
- This paper serves as a resource for bioanalysis validation in tissues.
