Disruptors Cause Controversy

And I can see in my mind this world of consumer driven affordable health care. And so we have to sort of create that, so we have to teach the consumer. So the regulatory side, when we launched, we believed like really simply I own myself. Like it's my body and my genome is just the digital representation of me. And so like, of course I can get access to it. Like why would I not be able to. That seems crazy. Like why would there be any prohibition? And then my taxpayer dollars go to all this genetics research. So why wouldn't I be able to get access to that? All I want to do is connect my own body, my genome, and understand what's happening with all this research. And I already paid for that research. I want to see what it is. So the idea was like, we're not interpreting, we're connecting the dots for you. And sorry, I was like cold. And so we just felt like it was information. It was almost like this is your first amendment right, like you can see. And from a lab perspective, we felt like we fell under clia, which is the Clinical Laboratory Information act managed by Medicare as a laboratory developed test. And so we in lots of blood tests, like blood tests today, and most genetic tests are all LDTs. So we felt like we were under that pathway clearly. One of the things that's interesting for me is especially from an academic perspective, the history of medicine is so interesting. And birth control tests used to be super controversial. And anytime the consumer is at the point of interaction, like it's a direct to consumer, that's really controversial. So we realized that we were just getting, there was a lot of controversy around us because of the direct to consumer. And so we did have sort of what's now known as the most well read ever warning letter by the FDA's history, which I actually, in some ways I'm really proud of. I think that that was a sign that we're doing something really different. It was sort of radical. It's the change that we want. And our approach to it has been to work with the agency and say, you know what, trying to fight with the agency or sort of that arrogance of, well, we'll show you. Part of it is that to really drive change, you have to change the system. And so for me, the best thing that we've done is then partner. Partner's not the right word, but that we actually listen, like we listened to the FDA and we said we're going to do all the things that you ask us to do and we're going to get a direct to consumer approval for our test.