Direct-to-Consumer Personal Genome Services: Need for More Oversight

TL;DRAbstract

Genetic tests have been developed for approximately 1,500 diseases. Most of these tests have not yet been incorporated into standard primary care due to limited evidence regarding their clinical validity and utility; the complex and not wellunderstood role that genes play in the development of many common diseases; physicians' limited knowledge of genetics; and public fear of genetic discrimination Despite these concerns, genetic tests are increasingly being sold direct-toconsumer (DTC)-predominantly over the Internet and with minimal or, in many cases, no involvement of health care professionals. The American public generally assumes that the government has assessed the safety and efficacy of all consumer (including medical) products. But there are significant gaps in the regulation of genetic testing that pose threats to consumer health and safety. Despite rapid scientific developments made during the last decade, the regulatory environment has changed very little

Chat with Paper

AI Agents for this Paper