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Cutpoint Methods in Digital Pathology and Companion Diagnostics

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Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development

Part of the book series: Methods in Pharmacology and Toxicology ((MIPT))

Abstract

Digital image analysis is quickly transforming pathology into a quantitative discipline, where numerous cellular features from individual cells in a tissue samples can be measured and analyzed. Furthermore, digital image analysis is bringing immunohistochemical methods to the forefront of biomarker research making them an integral part of drug development and personalized medicine. As hundreds of quantitative measures generated by digital image analysis of tissues can be correlated to clinical outcomes, the need grows for statistical methods to evaluate these quantitative approaches. Cutpoint analysis is one such statistical method often requested for analyzing data from tissue biopsy evaluation in drug development. This frequently is driven by the need to analyze biomarker expression data in relation to patient survival to stratify patients into subsets of responders and nonresponders to a particular drug treatment. In this chapter we discuss data and outcome-driven approaches in cutpoint analysis, and the caution that should be observed in using cutpoint analysis and appropriate methods for avoiding type I errors. Finally, we provide two examples of how cutpoint analysis can be applied in pharmaceutical datasets.

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Author information

Authors and Affiliations

  1. Flagship Biosciences, 7575 W 103rd Ave, Suite 102, Westminster, CO, 80021, USA

    Joshua C. Black Ph.D., Mahipal V. Suraneni & Steven J. Potts Ph.D.

Authors
  1. Joshua C. Black Ph.D.
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  2. Mahipal V. Suraneni
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  3. Steven J. Potts Ph.D.
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Corresponding author

Correspondence to Steven J. Potts Ph.D. .

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Editors and Affiliations

  1. Flagship Biosciences, LLC, Westminster, Colorado, USA

    Steven J. Potts

  2. University of North Carolina, Chapel Hill, North Carolina, USA

    David A. Eberhard

  3. Novartis Institutes for BioMedical Research, Cambridge, Massachusetts, USA

    Keith A. Wharton, Jr.

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© 2014 Springer Science+Business Media New York

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Black, J.C., Suraneni, M.V., Potts, S.J. (2014). Cutpoint Methods in Digital Pathology and Companion Diagnostics. In: Potts, S., Eberhard, D., Wharton, Jr., K. (eds) Molecular Histopathology and Tissue Biomarkers in Drug and Diagnostic Development. Methods in Pharmacology and Toxicology. Humana Press, New York, NY. https://doi.org/10.1007/7653_2014_34

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  • DOI: https://doi.org/10.1007/7653_2014_34

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  • Publisher Name: Humana Press, New York, NY

  • Print ISBN: 978-1-4939-2680-0

  • Online ISBN: 978-1-4939-2681-7

  • eBook Packages: Springer Protocols

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