Recommendations on biomarker assay validation (BAV) in tissues by GCC.

Biomarker analysis enables a deep understanding of physiological and biological processes and offers insights into pathological disease states and conditions. When measured in tissues, the spatial distribution of biomarkers may be evaluated. To meet regulatory and sponsor requirements, guidance on the approach to validation and the parameters to be evaluated is essential. The main goals of this GCC white paper are to disseminate the survey results discussed during the 16& 17GCC Closed Forums (2023 & 2024) and to provide recommendations from the GCC members on technical and regulatory considerations for the bioanalysis of biomarkers in tissues.