23andMe and the FDA clearance

23andMe and the FDA clearance

As they say, read all about it. I’m rather ambivalent. 23andMe has a business rationale to go in this direction, so I don’t begrudge them their decision. The problem, at least from a legal perspective, is that they’re providing medical advice at least implicitly. And I think this medical direction is really where the big money is in any case. There’s no angle standing on principle.

But, I still believe that on a deep level regulatory agencies don’t “get it.” Our own genotype and genome is going to be a cheap commodity in the next few years. Services like Promethease will proliferate to provide people open source information. Is openSNP going to the FDA anytime soon? The main reason that firms like 23andMe will go through regulatory hurdles is that they are, or aim to be, legitimate public entities. In other words this is an artifact of our institutions. Mind you, 23andMe et al. will probably always have slicker user interfaces, and there’s some value in that. But that doesn’t entail FDA oversight, does it?

The shift toward automation and computation are real ones, and I have a difficult time how seeing regulation developed in the 20th century …

Razib Khan