I was just about to order a kit to do an episode on 23andMe when the FDA shut ‘em down! So I’ll have to wait a while to get my first-hand reactions together. For those who don’t know, 23andMe is a company that offers personal genome sequencing and counseling direct by mail, all you have to do is spit in a tube.
Consumer genetic testing is, unsurprisingly, a complicated issue. The economics of DNA sequencing technology, meaning that sequencing whole genomes, billions of bases, is getting really cheap and really fast, makes it clear that someone, somewhere, if they are allowed to, is going to offer consumers the chance to get their own genome read. Getting DNA data, a lot of it, is just plain easy these days. And the ancestry part is cutesie-pie stuff. It’s the medical applications that bring on the comparisons (some warranted, some not) to GATTACA and Star Trek.
The hard part is figuring out what all that data means. Which differences are just sequencing errors and which are mutations? How much is just natural variation? What does a “normal” genome even look like? Most importantly: How do we really tell whether a mutation will increase someone’s risk for a disease to the point that they and their doctor need to do something about it?
Many people think that they should have unobstructed access to discovering the DNA bases that make their genome. But when that genome sequence starts being used to diagnose people or to guide medical treatment, that’s the FDA’s territory, and they take that stuff very seriously. 23andMe wasn’t playing ball, so they got in trouble.
What will happen now? Is consumer genetic testing the Right Way™? Or should this be managed by doctors and federal regulators? I don’t know. Hundreds of thousands of words will be written on this subject before it’s said and done.
If you’d like to read some of those words, and get some opinions from some very smart people, here’s a whole mess of ‘em: