The mere fact that 23andMe was able to operate for six years without marketing approval speaks to how much leeway the FDA was willing to extend at first, especially while many doctor’s groups were skeptical of personal genetics from the beginning…
23andMe didn’t invent the saliva test, after all. All it did was bring such testing outside the doctor’s office and make it available without the headaches of the health-insurance system. It was a consumer-grade version of a professional service: cheaper, easier, and not quite as good. And because the testing could be done in bulk, the service added a lot of genes that would never be tested in a medical lab…But that same fast-and-loose approach can cause problems if a faulty test turns up in an area with real medical complications…And when the bad news does arrive…23andMe didn’t have any counselors on hand to guide users to the medical options available or provide the proper context for understanding the results. Even if the service solves its marketing problems, those issues are likely to remain.
This is probably the best article I’ve read on 23andMe and the FDA’s action. For all intents and purposes, 23andMe seemed more concerned with pursuing its product than dealing with the implications of putting complex medical information into consumers’ hands.