Abstract
In the last decade an increasing number of collaborations were established between pharma and diagnostic companies on the development of companion diagnostic assays to identify patients that will most likely respond to targeted therapies under development. This chapter focuses on the development of immunohistochemistry assays as companion diagnostics, which includes biomarker expression and specimen types, antibody selection and optimization, assay protocol development and optimization, assay verification and validation, and clinical validation. Past examples of companion diagnostic assay development, timeline coordination of drug-diagnostic co-development, and regulatory considerations are also briefly discussed.
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Chau, M., Askaa, J. (2014). Tissue-Based Companion Diagnostics: Development of IHC Assays from an Industry Perspective. 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_26
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DOI: https://doi.org/10.1007/7653_2014_26
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