Immunohistochemistry In Precision Medicine: From Biomarker To Clinical Trial Assay

By Amanda Woodrooffe, PhD and Dawn Butler

Immunohistochemistry (IHC) plays a pivotal role in the advancement of precision medicine by enabling the visual detection and spatial localization of biomarkers within tissue samples. IHC informs all phases of therapeutic development—from biomarker discovery to clinical trial assay (CTA) implementation—by supporting diagnosis, prognosis, treatment prediction, and patient stratification. At Precision for Medicine, IHC is used to validate disease targets, assess biodistribution and off-target effects, guide patient enrollment, and inform therapeutic eligibility, all while accelerating clinical timelines and improving trial design.

Key to success in IHC is the development of robust, reproducible assays using validated antibodies, optimized antigen retrieval methods, and rigorous controls. Precision leverages tissue microarrays (TMAs) and formalin-fixed paraffin-embedded (FFPE) samples to evaluate biomarker expression across disease stages. From preclinical validation to clinical implementation, IHC is essential in understanding target biology and ensuring drug safety and efficacy. Precision for Medicine offers comprehensive services—including custom assay development, centralized pathology, and global deployment—that enable the successful integration of IHC into therapeutic development pipelines, supporting more personalized, effective treatment strategies for patients.