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Impact of Analytical Variables in Breast Cancer Biomarker Analysis

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Molecular Pathology of Breast Cancer

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Abstract

Assessment of biomarkers for tissues is a demanding science. Scientific rigor in the analytical methodology is the key to obtaining standardized and consistent results. In this chapter, we focus on the analytical variables, both assay variables and reporting variables, in biomarker analysis. Each and every step in the assay process needs to be carefully monitored, optimized and standardized. Using immunohistochemistry and in situ methods as a background, we describe in detail the parameters required for staining. Assessment of the staining requires the evaluation of not only the tumor staining but also presence of staining in the internal controls such as normal breast epithelium. Strict laboratory quality control using both internal and external quality assessment metrices is necessary. Adoption of national and international guidelines such as ASCO-CAP guidelines, when available, is necessary to provide high degree of confidence required for biomarker analysis that is critical in this era of precision medicine.

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Authors and Affiliations

  1. University of Westminster, 115 New Cavendish Street, London, W1W 6UW, UK

    Anthony Warford

  2. Department of Pathology, Targos Molecular Pathology GmbH, D-34119, Kassel, Germany

    Bharat Jasani

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  1. Anthony Warford
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  2. Bharat Jasani
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Correspondence to Anthony Warford .

Editor information

Editors and Affiliations

  1. Pathology & Laboratory Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA

    Sunil Badve

  2. Indiana University School of Medicine, Dept of Pathology & Laboratory Medicine Indiana University School of Medicine, Indianapolis, Indiana, USA

    Yesim Gökmen-Polar

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Warford, A., Jasani, B. (2016). Impact of Analytical Variables in Breast Cancer Biomarker Analysis. In: Badve, S., Gökmen-Polar, Y. (eds) Molecular Pathology of Breast Cancer. Springer, Cham. https://doi.org/10.1007/978-3-319-41761-5_3

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