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Every patient is unique, and the evolving field of precision medicine aims to ensure that the right treatment is delivered to the right patient at the right time. To achieve this, health care providers are increasingly turning to advanced technologies known as biomarker tests for molecularly targeted therapies. These tests can identify molecular variations specific to an individual patient and help determine the most effective therapy for a patient’s disease or avoid treatments that may be ineffective or harmful. The Institute of Medicine of the National Academies of Sciences, Engineering, and Medicine appointed a committee of experts to examine this question. In this report, the committee recommends an integrated set of actions aimed at addressing clinical practice, regulatory and reimbursement policy, and data challenges through the framework of a rapid learning system.