直接面向消费者的基因检测：公众是否准备好接受简单的家庭DNA检测来检测疾病风险？

Direct-To-Consumer Genetic Testing: Is the Public Ready for Simple, At-Home DNA Tests to Detect Disease Risk?

作者信息

Bates Mary

出版信息

IEEE Pulse. 2018 Nov-Dec;9(6):11-14. doi: 10.1109/MPUL.2018.2869315.

DOI:10.1109/MPUL.2018.2869315

Abstract

Most genetic testing requires a doctor's prescription. In April 2017, however, the U.S. Food and Drug Administration (FDA) gave genetics company 23andMe the go-ahead to sell DNA tests assessing the user's level of risk for ten health conditions, including Parkinson's disease and late-onset Alzheimer's disease. This was followed nearly a year later by approval to sell tests for three mutations in the genes BRCA1 and BRCA2 linked to increased breast cancer risk. These remain the only FDA-approved direct-to-consumer (DTC) tests for genetic risk of disease.

摘要

大多数基因检测都需要医生的处方。然而，2017年4月，美国食品药品监督管理局（FDA）批准基因公司23andMe出售DNA检测产品，这些检测可评估用户患帕金森病和晚发性阿尔茨海默病等十种健康疾病的风险水平。近一年后，该公司又获批出售检测与乳腺癌风险增加相关的BRCA1和BRCA2基因中三种突变的产品。这些仍然是FDA批准的仅有的直接面向消费者（DTC）的疾病遗传风险检测产品。