The regulatory landscape of precision oncology laboratory medicine in the United States - Perspective on the past 5 years and considerations for future regulation

被引：7

作者：

Konnick, Eric Q. ^{[1
,2
]}

机构：

[1] Univ Washington, Dept Lab Med, Seattle, WA 98195 USA

[2] Box 357110,1959 NE Pacific St,NW120 Seattle, Seattle, WA 98195 USA

来源：

PRACTICAL LABORATORY MEDICINE | 2020年 / 21卷

关键词：

Oncology; Regulation; Testing; LDTs; FDA; CLIA; CMS; BRAF MUTATIONS; GENERATION; KRAS; EGFR; NGS;

D O I：

10.1016/j.plabm.2020.e00172

中图分类号：

R446 [实验室诊断]; R-33 [实验医学、医学实验];

学科分类号：

1001 ;

摘要：

The regulatory landscape for precision oncology in the United States is complicated, with multiple governmental regulatory agencies with different scopes of jurisdiction. Several regulatory proposals have been introduced since the Food and Drug Administration released a draft guidance to regulate laboratory-developed tests in 2014. Key aspects of the most recent proposals and discussion of central arguments related to the regulation of precision oncology laboratory tests provides insight to stakeholders for future discussions related to regulation of laboratory tests.

引用

页数：7

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