23andMe CEO Wojcicki： How the FDA changed our business ｜ Fortune MPW

So 23andMe, the company, actually has sort of two lives as I see it, so there's the pre-FDA letter and the post-FDA letter. The pre-FDA letter, somebody would take the test and get 250 reports on everything from your risk for various diseases, what kind of adverse reaction you might have to drugs, just a really intense description. Then you got that threatening letter from the FDA last, almost exactly a year ago, and now you had to really whittle that back. So describe what people can get now and where you are with the FDA. Sure. We launched originally back in 2007 with 12 reports, and people were nervous, like how are people going to respond to this genetic information? And very quickly after we launched, we got encouragement from the scientific community to just give as much information back to individuals as possible because it was so exciting and so interesting to watch. November 22nd of last year, we got a letter from the FDA asking us or telling us to stop giving health-related information back to consumers and that we are a medical device and we need to file as a medical device. So we are no longer providing health information back to individuals. We are, for instance, in all of your bags you have the saliva kit, you spit in that, we will give you back your raw data and we will give you back all your ancestry information. And you can do anything you want with your own raw data in your genome, so you can look up information yourself, but 23andMe is not allowed to tell you to draw those associations for you right now. We did submit to the FDA what's called a 510k package. It is on a single association, so we did have 250 reports. So we've essentially given a submission package for one report and we are hopeful that we can at least establish through that report a path forward. Moving forward with the FDA.