Translating Immuno-oncology Biomarkers to Diagnostic Tests: A Regulatory Perspective

  • You Li
  • Janaki Veeraraghavan
  • Reena PhilipEmail author
Part of the Methods in Molecular Biology book series (MIMB, volume 2055)


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.

Key words

Companion diagnostic Biomarker Immuno-oncology Cancer immunotherapy FDA Assay validation 


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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2020

Authors and Affiliations

  1. 1.OHT7/ Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality, Center for Diagnostics and Radiological HealthU.S. Food and Drug AdministrationSilver SpringUSA

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