CDx、NGS 和监管：Pistoia 联盟的五个视角。
CDx, NGS and regulation: five perspectives from the Pistoia Alliance.
机构信息
Pistoia Alliance, Wakefield, MA, USA.
Pistoia Alliance, Wakefield, MA, USA.
出版信息
Drug Discov Today. 2019 Nov;24(11):2120-2125. doi: 10.1016/j.drudis.2019.07.002. Epub 2019 Jul 12.
Companion diagnostics (CDx) are essential to the practice of precision medicine. Next-generation sequencing is an increasingly important tool in the development of CDx. However, for CDx to be deployed, many different biopharma industry sectors need to collaborate. This paper outlines some of the challenges and opportunities perceived by the biopharmaceutical industry, the Europe Molecular Quality Network, a regulatory agency, a notified body and a CDx service provider.
伴随诊断（Companion Diagnostics，CDx）是精准医学实践的重要组成部分。下一代测序（Next-generation sequencing）是 CDx 开发中越来越重要的工具。然而，要部署 CDx，许多不同的生物制药行业部门需要合作。本文概述了生物制药行业、欧洲分子质量网络（Europe Molecular Quality Network）、监管机构、通知机构和 CDx 服务提供商所感知到的一些挑战和机遇。
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