(Recorded live on Thursday, April 16, 2020)
Image analysis of histological tissue sections is a fast-growing field that is becoming widely accepted as a research tool for scientists and pathologists, providing quantitative, reproducible data in lieu of varying manual pathology interpretations.
Using image analysis to quantitate biomarker staining in tissue sections can be challenging due to the added layer of image complexity introduced by immunohistochemical or in-situ signals. Additional challenges are introduced by the nature of tissues within a clinical trial setting, including varied tissue/disease indications, biopsy methods, and the variety of biomarker stains necessary to characterize drug efficacy.
To utilize biomarker image analysis in a clinical trial setting, special care must be taken to integrate clinicians into the workflow and ensure analytical rigor is in line with CAP/CLIA standards during the course of assay development, validation, and testing.
Dr. Chuck Caldwell explains the Flagship approach in this webcast recorded in April, 2020.