Abstract
Clinical assay development is quite different from preclinical assay development, since a clinical assay requires special considerations to make sure a biomarker discovered preclinically will be translatable into clinical settings. Once the assay is developed, its pre-analytical and analytical validity will be confirmed through a series of analytical validation experiments that will document its performance characteristics. One challenge frequently encountered during the clinical sample testing is that many samples fail to meet minimum sample requirements, either due to the low quality or due to insufficient quantity. Special considerations are often needed for selecting biomarker assay platforms depending on the type of tissues used in the clinical trials. In this chapter, we provided a brief overview of most frequently encountered clinical genomic assays and dissected many of them to show their practical application in clinic based on our experiences.
Financial and Competing Interest Disclosure
Both authors are full-time employees of Merck & Co. and own Merck stock.
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Chang, K.C.N., Marton, M.J. (2016). Clinical Genomic Biomarker Assay Development: Technologies and Issues. In: Weiner, R., Kelley, M. (eds) Translating Molecular Biomarkers into Clinical Assays . AAPS Advances in the Pharmaceutical Sciences Series, vol 21. Springer, Cham. https://doi.org/10.1007/978-3-319-40793-7_15
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