Hayes Daniel F, Schott Anne F
Ann Arbor, Michigan.
Trans Am Clin Climatol Assoc. 2015;126:133-43.
The era of genomics-based medicine promises to provide molecular tests that will permit precision medicine. However, in 2015, it is not clear what the terms genomics-based medicine, molecular tests, or precision medicine mean. In this report, we review the definitions of these terms and other important semantics relative to what it takes to get a tumor biomarker into standard clinical practice, and the potential clinical trial designs that are being considered to determine if tumor biomarker tests based on next-generation sequencing actually provide benefit to patients with cancer.
基于基因组学的医学时代有望提供能实现精准医疗的分子检测。然而,在2015年,基于基因组学的医学、分子检测或精准医疗这些术语的含义尚不明晰。在本报告中,我们回顾了这些术语的定义以及与将肿瘤生物标志物纳入标准临床实践所需条件相关的其他重要语义,还探讨了正在考虑的潜在临床试验设计,以确定基于新一代测序的肿瘤生物标志物检测是否真的能使癌症患者获益。