Abstract
Companion diagnostics has fully gained its footing in the development cycle of targeted therapeutics. There is universal acknowledgement for the need of companion diagnostics from regulatory bodies, drug development organizations, physicians, and insurance payers. The companion diagnostic plays an integral role in selecting or excluding patients for a specific therapy and its development is a significant endeavor. The drug developer and the diagnostic manufacturer have visible roles in this undertaking. The role of a third entity—the biomarker laboratory—is vital to the successful regulatory approval; however its responsibilities are less known. When utilized well, the biomarker laboratory can serve as a potent development partner for both the drug developer and the diagnostic manufacturer from the origin of the assay to its fully realized function as a companion diagnostic. In this chapter we describe the roles of the biomarker laboratory, examine the required infrastructure and skills sets, distinguish the differences between itself and the traditional diagnostic laboratory, and provide guidelines of operations based on our experiences with multiple companion diagnostics programs.
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Kockx, M., de Schepper, S., Ung, C. (2014). Development of Tissue-Based Companion Diagnostics: The Relationship Between the Pharmaceutical Company, Diagnostic Partner, and the Biomarker Laboratory. 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_24
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DOI: https://doi.org/10.1007/7653_2014_24
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