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拆毁壁垒:FDA 批准用于癌症基因组变异的下一代测序(NGS)检测。

Tearing down the walls: FDA approves next generation sequencing (NGS) assays for actionable cancer genomic aberrations.

机构信息

Oncogenomics and Epigenetics, IRCSS Regina Elena National Cancer Institute, Rome, Italy.

Regina Elena NGS group, IRCSS Regina Elena National Cancer Institute, Rome, Italy.

出版信息

J Exp Clin Cancer Res. 2018 Mar 5;37(1):47. doi: 10.1186/s13046-018-0702-x.

Abstract

The United States Food and Drug Administration (FDA) recently approved the clinical use of two comprehensive 'mid-size' Next Generation Sequencing (NGS) panels calling actionable genomic aberrations in cancer. This is the first endorsement, by a regulatory body, of a new standard of care in oncology. Herein, we argue that besides its many practice-changing implications, this approval tears down the conceptual walls dividing system biology from clinical practice, diagnosis from research, prevention from therapy, cancer genetics from cancer genomics, and computational biology from empirical therapy assignment.

摘要

美国食品和药物管理局(FDA)最近批准了两种全面的“中型”下一代测序(NGS)面板的临床使用,以确定癌症中的可操作基因组异常。这是监管机构首次认可肿瘤学中新的护理标准。在此,我们认为,除了具有许多改变实践的意义外,这一批准还打破了将系统生物学与临床实践、诊断与研究、预防与治疗、癌症遗传学与癌症基因组学以及计算生物学与经验性治疗分配分开的概念性障碍。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2dd0/5838869/6741c253e40b/13046_2018_702_Fig1_HTML.jpg

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