23andMe Has Accelerated The Consumer Genomics Debate

24 Feb 2014

23andMe’s battle with FDA is another reminder that genomics is rapidly becoming incorporated not only into the clinic, but also into everyday life. It is forcing FDA and other agencies to take a stand on critical technical, legal, and ethical issues, which will influence the strategies of medical diagnostics and pharmaceutical companies as well as labs performing tests directly for the consumer.

Since mid-January, commentaries have run in Nature, The New England Journal of Medicine (NEJM), and The Journal of the American Medical Association discussing consumer genomics company 23andMe Inc.’s tug of war with the US Food and Drug Administration, which in December resulted in 23andMe halting new consumer access to health-related data from its Personal Genome Service (PGS). (See Also see "FDA Comes Down Hard On 23andMe, Putting Consumer-Directed Genetic Testing On Notice" - Medtech Insight, 16 December, 2013..) The rapid appearance of these articles, along with a timely report from a presidential bioethics advisory committee, has heightened awareness that genomics is rapidly becoming incorporated not only into the clinic, but into everyday life.

The consumer genomics horse is out of the barn. Demand for the technology is forcing FDA and other agencies to...