California and New York regulators have been in the news lately (such as here and here), with their attempts to crack down on the nascent direct-to-consumer genetic testing industry. These states argue that companies like 23andMe, Navigenics, and several others, are offering unproven and unlicensed clinical tests directly to consumers. Are the services offered by these companies clinical tests, subject to the normal regulations of other clinical tests? Should the government be able to stop you from getting your DNA sequenced?
The answer to the second question is a flat-out no. The government has no legitimate reason to prevent you from getting genotyped. The technology used by these personal genetics companies is very good - in the future, this technology will be cheaper and cover more variants in your genome, but what is available right now is very good. And there are reasonable non-clinical reasons to get yourself sequenced, out of sheer curiosity, or for genealogy purposes, for example. More importantly, this sequence data is a permanent resource for you. Although we may not have very good clinical tests for complex genetic diseases right now, we'll have them in the future, and any DNA sequencing you get done now will be suitable for these future analyses. Once you have your raw DNA data in hand, it's there if you need it in the future.
So, as things stand now, the genotyping serviced offered by 23andMe, DecodeMe, and Navigenics have enough non-clinical use to justify themselves, and these services should not be blocked by state regulators. But simply offering people DNA sequencing is one thing - making disease risk predictions is another.
