Recent advances in cancer therapy are based on agents that specifically target the products of the genes mutated in cancer cells. Development of companion diagnostic tests for these agents can simplify the drug-discovery process, make clinical trials more efficient and informative, and be used to individualize the therapy of cancer patients. Companion diagnostic development has many challenges. Examples include the reluctance of drug companies to restrict the use of their drugs through biomarker tests, difficulties of developing companion diagnostics from discovery to clinical validation, and the regulatory challenges in developing effective mechanisms to synchronize reviews of therapeutics with diagnostic devices used to personalize treatment. This article addresses the various challenges in developing companion diagnostics along with the US FDA's approach to regulation of companion diagnostic devices.
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Philip et al. (2011) studied this question.