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Development of Gene Expression-Based Biomarkers on the nCounter® Platform for Immuno-Oncology Applications

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Biomarkers for Immunotherapy of Cancer

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

Abstract

Biomarkers based on transcriptional profiling can be useful in the measurement of complex and/or dynamic physiological states where other profiling strategies such as genomic or proteomic characterization are not able to adequately measure the biology. One particular advantage of transcriptional biomarkers is the ease with which they can be measured in the clinical setting using robust platforms such as the NanoString nCounter system. The nCounter platform enables digital quantitation of multiplexed RNA from small amounts of blood, formalin-fixed, paraffin-embedded tumors, or other such biological samples that are readily available from patients, and the chapter uses it as the primary example for diagnostic assay development. However, development of diagnostic assays based on RNA biomarkers on any platform requires careful consideration of all aspects of the final clinical assay a priori, as well as design and execution of the development program in a way that will maximize likelihood of future success. This chapter introduces transcriptional biomarkers and provides an overview of the design and development process that will lead to a locked diagnostic assay that is ready for validation of clinical utility.

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Author information

Authors and Affiliations

  1. NanoString Technologies, Inc., Seattle, WA, USA

    Sarah Warren, Patrick Danaher, Afshin Mashadi-Hossein, Lynell Skewis, Brett Wallden, Sean Ferree & Alessandra Cesano

  2. ESSA Pharma, South San Francisco, CA, USA

    Alessandra Cesano

Authors
  1. Sarah Warren
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  2. Patrick Danaher
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  3. Afshin Mashadi-Hossein
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  4. Lynell Skewis
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  5. Brett Wallden
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  6. Sean Ferree
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  7. Alessandra Cesano
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Corresponding author

Correspondence to Sarah Warren .

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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Warren, S. et al. (2020). Development of Gene Expression-Based Biomarkers on the nCounter® Platform for Immuno-Oncology Applications. 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_13

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  • DOI: https://doi.org/10.1007/978-1-4939-9773-2_13

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  • Publisher Name: Humana, New York, NY

  • Print ISBN: 978-1-4939-9772-5

  • Online ISBN: 978-1-4939-9773-2

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