Reflections on the US FDA's Warning on Direct-to-Consumer Genetic Testing
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...
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BioMed Central
2014-12-01
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| Series: | Genomics & Informatics |
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| Online Access: | http://genominfo.org/upload/pdf/gni-12-151.pdf |
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| author | Seon-Hee Yim Yeun-Jun Chung |
| author_facet | Seon-Hee Yim Yeun-Jun Chung |
| author_sort | Seon-Hee Yim |
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| description | 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. |
| format | Article |
| id | doaj-art-da9174cf56014142b0a9f9f7cfe0958a |
| institution | Kabale University |
| issn | 1598-866X 2234-0742 |
| language | English |
| publishDate | 2014-12-01 |
| publisher | BioMed Central |
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| series | Genomics & Informatics |
| spelling | doaj-art-da9174cf56014142b0a9f9f7cfe0958a2025-02-02T10:22:29ZengBioMed CentralGenomics & Informatics1598-866X2234-07422014-12-0112415115510.5808/GI.2014.12.4.151100Reflections on the US FDA's Warning on Direct-to-Consumer Genetic TestingSeon-Hee Yim0Yeun-Jun Chung1Department 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.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.http://genominfo.org/upload/pdf/gni-12-151.pdfdirect-to-consumer genetic testingmedical deviceregulation |
| spellingShingle | Seon-Hee Yim Yeun-Jun Chung Reflections on the US FDA's Warning on Direct-to-Consumer Genetic Testing Genomics & Informatics direct-to-consumer genetic testing medical device regulation |
| title | Reflections on the US FDA's Warning on Direct-to-Consumer Genetic Testing |
| title_full | Reflections on the US FDA's Warning on Direct-to-Consumer Genetic Testing |
| title_fullStr | Reflections on the US FDA's Warning on Direct-to-Consumer Genetic Testing |
| title_full_unstemmed | Reflections on the US FDA's Warning on Direct-to-Consumer Genetic Testing |
| title_short | Reflections on the US FDA's Warning on Direct-to-Consumer Genetic Testing |
| title_sort | reflections on the us fda s warning on direct to consumer genetic testing |
| topic | direct-to-consumer genetic testing medical device regulation |
| url | http://genominfo.org/upload/pdf/gni-12-151.pdf |
| work_keys_str_mv | AT seonheeyim reflectionsontheusfdaswarningondirecttoconsumergenetictesting AT yeunjunchung reflectionsontheusfdaswarningondirecttoconsumergenetictesting |