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Updated: Jan 19, 2026

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Published on: January 22, 2011
Translating Immuno-oncology Biomarkers to Diagnostic Tests: A Regulatory Perspective
You Li1, Janaki Veeraraghavan1, Reena Philip2
1OHT7/ Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality, Center for Diagnostics and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.
Abstract:
The rapid development of effective immunotherapy using immune-checkpoint inhibitors (ICIs) against many different cancer types opened a new front in cancer treatment. Immunotherapy is undoubtedly one of the biggest breakthroughs in cancer therapy within the past decade. The identification of predictive biomarkers to select the patients most likely to respond to ICI monotherapies or emerging combination therapies remains one of the major unmet needs for the oncology community.This chapter provides an overview of existing and emerging biomarkers associated with ICI response. Additionally, using several case studies of FDA approved or authorized in vitro diagnostic oncology devices, this chapter also provides an overview of analytical and clinical validation considerations of diagnostic tests for immuno-oncology biomarkers.
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