Tuesday, August 1, 2017

The FDA, 23andMe, and selling less for more

Back in 2013 and at the beginning of the FDA vs 23andMe story, I wrote this:
Personal genetics will elicit a huge change in medicine, [but] actually doing that requires knowledge of how a person's genetics impacts their health.  For many genes, like BRCA1/2 which are the oft cited breast cancer risk markers in the media, the links between genetics and disease are established.

But for many others, a lot of work still needs to be done: clinical trials based on experiments need to be designed; experiments based on hypotheses need to be run; hypotheses flowing from data analyses need to be identified; and analyses need data sets to start from.  Fuzzy data is better than no data at all.

I expect that's where 23andMe is going to graciously come into play.  If the FDA actually winds up killing the company's main data collection channel, the company already has about 400,000 people genotyped and has built up enough traction to run for a while without having to sell another $99 test for a long time.

It took four years, but as of a few months ago, the FDA has reversed it's decision against 23andMe allowing the company to resume DTC marketing. The catch, however, is that the company will now offer tests for 36 conditions (instead of 254) for $199 (instead of $99). Gizmodo correctly points out that though this means that people are getting "less info for more money" (more on that in another post). Technically, that may be true, but if that information is more accurate or at least less irrelevant it counts for some of that value.