直接面向消费者的基因检测：在医疗保健中的价值视角。

Direct-to-consumer genetic testing: Perspectives on its value in healthcare.

机构信息

Coriell Institute for Medical Research, Camden, New Jersey, USA.

出版信息

Clin Pharmacol Ther. 2016 Feb;99(2):146-8. doi: 10.1002/cpt.287. Epub 2015 Nov 25.

Abstract

The direct-to-consumer genetic testing debate reached a fever pitch in November 2013 when the US Food and Drug Administration (FDA) instructed 23andMe to discontinue marketing and sale of their Personal Genome Service. In 2015, 23andMe emerged with FDA approval to market a carrier test for Bloom syndrome only, and plans to release additional reports. The dust has settled and it is time to ask: What have we learned, and where do we go from here?

摘要

2013 年 11 月，美国食品和药物管理局（FDA）指示 23andMe 停止营销和销售其个人基因组服务，直接面向消费者的基因检测辩论达到了白热化的程度。2015 年，23andMe 获得 FDA 批准，仅可营销布卢姆综合征携带者检测，并计划发布更多报告。尘埃落定，现在是时候问：我们学到了什么，我们从这里走向何方？