Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Pharmacotherapy. 2017 Sep;37(9):1000-1004. doi: 10.1002/phar.1971. Epub 2017 Jul 26.
Advancing the use of biomarkers and pharmacogenomics has been a key priority area for the U.S. Food and Drug Administration (FDA). The FDA offers prescribing recommendations to manage ~100 gene-drug interactions, and multiple institutions around the United States and abroad have incorporated genomic testing into patient care. However, the penetration of pharmacogenomic testing remains incomplete. In this perspective, we summarize the evidence streams to support the clinical utility of pharmacogenomic testing and its transition into clinical practice.
推进生物标志物和药物基因组学的应用一直是美国食品和药物管理局（FDA）的一个重点优先领域。FDA 提供了约 100 种与基因-药物相互作用相关的处方建议，美国和国外的多个机构已经将基因组测试纳入患者护理中。然而，药物基因组测试的普及率仍然不完全。在这篇观点文章中，我们总结了支持药物基因组测试临床实用性及其向临床实践转化的证据流。
