4 ms·
That's comforting: evidently at least that is considered more or less accurate. I'm not sure you can safely draw that conclusion from the way this has played o
by rosser 13y ago
That's comforting: evidently at least that is considered more or less accurate.
I'm not sure you can safely draw that conclusion from the way this has played out. I think it's equally, if not more likely, that 23andMe is able to continue offering raw and ancestry data simply because those things are outside the FDA's purview.
Consider, by analogy, the dietary supplement industry: the FDA has incredibly more power over a product that is advertised or marketed as intended to "diagnose, treat, or cure any disease." Notice how the manufacturer explicitly disclaims that exact verbiage on all those sorts of products? That's because anything that is marketed that way is immediately subject to a much higher degree of FDA jurisdiction, under which they can literally shut you down overnight.
When 23andMe runs your genome and sees a genotypic match for an arbitrary disease, and then tells you that you have that disease, they're diagnosing you. When they tell you that you're 72.3% Northern European, or give you a ginormous CSV (or however they encode their data dumps), they aren't.
That's the only thing I think you can meaningfully read from this situation: they're changing the way their product is marketed, and the services they provide, so as not to be subject to the FDA's nuclear option.
- Steuard 13y agoThat's a really good point. Rats. So only if they go back to advertising health information after FDA approval will we be able to be confident that their actual genotype results meet FDA standards (as well as their interpretive text).