Advancing IHC Assays From RUO To Clinical Trials And CDx

By Kennon Daniels, PhD, and Angelique Heckmann, PhD

Early-phase biomarker programs can become significantly more complex when an exploratory IHC assay must support patient selection across multiple indications and regulatory regions. This case study follows the evolution of an IHC assay from exploratory development into a structured clinical diagnostics program spanning the US, UK, and EU. It examines how assay development, cutoff establishment, analytical validation, biospecimen access, regulatory strategy, and sustained subject matter expert involvement were coordinated as the program expanded.

Access the full resource below to see how scientific and regulatory functions were integrated to support a growing biomarker-driven clinical program.