Abstract
Companion and complementary diagnostics are important elements in the realization of precision medicine. The number of drugs that have this type of assay linked to their use is rapidly increasing, and within oncology they have had major impact on drug development and on how these drugs are used in the clinic. Most pharmaceutical companies have recognized that the full therapeutic potential of a targeted cancer drug can only be realized if a companion diagnostic assay is developed concomitantly using the drug-diagnostic codevelopment model. However, with the increased molecular understand of pathophysiology and disease heterogeneity, the companion diagnostic assays based on single biomarker detection will need to be supplemented by assays with a more complex signature. In this chapter, a brief introduction will be given to companion and complementary diagnostics with specific attention paid to the clinical development and the regulatory requirements.
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