Consumer genetic tests like 23andMe aren't medical devices, and the FDA shouldn't regulate them like blood-sugar meters or pregnancy tests.
Despite the FDA's recent ban on 23andMe's personal genome analysis, we still don't know how best to regulate personal genome information.
Can scientific advances and patient privacy coexist?
Genome theft is already a possibility, and that problem looks like it's only going to grow.
The single participant in a groundbreaking—and controversial—study is forcing clinicians to confront the thorny ethical issues surrounding the sequencing of individual genomes to offer a glimpse at what the future of medicine may look like.