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Biomarkers for Immunotherapy of Cancer pp 701–716Cite as

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

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Part of the book series: Methods in Molecular Biology ((MIMB,volume 2055))

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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Author information

Author notes

  1. You Li and Janaki Veeraraghavan contributed equally to this work.

Authors and Affiliations

  1. OHT7/ 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

    You Li, Janaki Veeraraghavan & Reena Philip

Authors
  1. You Li
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  2. Janaki Veeraraghavan
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  3. Reena Philip
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Corresponding author

Correspondence to Reena Philip .

Editor information

Editors and Affiliations

  1. NIH, National Cancer Institute, Bethesda, MD, USA

    Magdalena Thurin

  2. Nanostring Technologies, Seattle, WA, USA, ESSA Pharma, South San Francisco, CA, USA

    Alessandra Cesano

  3. Refuge Biotechnologies, Menlo Park, CA, USA

    Francesco M. Marincola

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Li, Y., Veeraraghavan, J., Philip, R. (2020). Translating Immuno-oncology Biomarkers to Diagnostic Tests: A Regulatory Perspective. In: Thurin, M., Cesano, A., Marincola, F. (eds) Biomarkers for Immunotherapy of Cancer. Methods in Molecular Biology, vol 2055. Humana, New York, NY. https://doi.org/10.1007/978-1-4939-9773-2_31

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  • DOI: https://doi.org/10.1007/978-1-4939-9773-2_31

  • Published:

  • Publisher Name: Humana, New York, NY

  • Print ISBN: 978-1-4939-9772-5

  • Online ISBN: 978-1-4939-9773-2

  • eBook Packages: Springer Protocols

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