The shift to personalized medicine, which supports medical treatment tailored to individual patient characteristics, has been hindered by uncertainty over the value, accuracy, and clinical utility of companion diagnostic tests. Even for the handful of drugs approved by FDA with labeling that links prescribing to specific biomarker measures, health plan operators, providers, and payers
frequently question the need to cover the added testing, according to analysis by Joshua Cohen of the Tufts Center for the Study of Drug Development (CSDD). Cohn noted at a recent CBI conference on “Precision Medicine and Companion Diagnostics” that only a few therapies have been approved by FDA
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inform prescribing; several more drugs gain links to specific diagnostics post- approval.