Yim Seon-Hee, Chung Yeun-Jun
Department of Medical Education, Integrated Research Center for Genome Polymorphism, MRC, College of Medicine, The Catholic University of Korea, Seoul 137-701, Korea.
Department of Microbiology, Integrated Research Center for Genome Polymorphism, MRC, College of Medicine, The Catholic University of Korea, Seoul 137-701, Korea.
Genomics Inform. 2014 Dec;12(4):151-5. doi: 10.5808/GI.2014.12.4.151. Epub 2014 Dec 31.
In November 2013, the US Food and Drug Administration (FDA) sent a warning letter to 23andMe, Inc. and ordered the company to discontinue marketing of the 23andMe Personal Genome Service (PGS) until it receives FDA marketing authorization for the device. The FDA considers the PGS as an unclassified medical device, which requires premarket approval or de novo classification. Opponents of the FDA's action expressed their concerns, saying that the FDA is overcautious and paternalistic, which violates consumers' rights and might stifle the consumer genomics field itself, and insisted that the agency should not restrict direct-to-consumer (DTC) genomic testing without empirical evidence of harm. Proponents support the agency's action as protection of consumers from potentially invalid and almost useless information. This action was also significant, since it reflected the FDA's attitude towards medical application of next-generation sequencing techniques. In this review, we followed up on the FDA-23andMe incident and evaluated the problems and prospects for DTC genetic testing.
2013年11月，美国食品药品监督管理局（FDA）向23andMe公司发出警告信，责令该公司停止23andMe个人基因组服务（PGS）的营销，直至其获得该设备的FDA营销授权。FDA将PGS视为未分类的医疗器械，这需要上市前批准或重新分类。FDA这一行动的反对者表达了他们的担忧，称FDA过于谨慎且家长式作风，这侵犯了消费者权利，可能会阻碍消费者基因组学领域本身的发展，并坚称该机构在没有伤害的实证证据的情况下，不应限制直接面向消费者（DTC）的基因检测。支持者支持该机构的行动，认为这是在保护消费者免受潜在无效且几乎无用的信息的影响。这一行动也具有重要意义，因为它反映了FDA对下一代测序技术医学应用的态度。在本综述中，我们追踪了FDA-23andMe事件，并评估了DTC基因检测的问题和前景。
