Love them or hate them, everyone seems to have an opinion on 23andMe. It’s hard not to admire Anne Wojcicki and her team for their determination. That their test for Bloom Syndrome is now FDA approved is testament to their willingness to work with the regulators. That they won’t go back to market in the USA until they have regulatory approval for more of their tests, shows their commitment to delivering the product they believe the consumer deserves.
I’m still undecided on direct-to-consumer testing. In general, I’m in favour of recreational genetics. It can be fun, and is a great way to get people engaged with the science behind it. But, it can also be frightening if you suddenly find out you’re at a higher risk of developing life threatening diseases. Fortunately, there is a lot of working going on at the FDA to understand which tests require a qualified healthcare professional to deliver the result.
The other big news on 23andMe has been their partnerships with Pfizer and Genentech. I’m really excited to find out what kind of success drug developers have using the database. The partnerships did also raise a few questions around the nature of the consent form customers filled out (but nothing sinister!). It must be an exciting time to be at 23andMe. It’s also an exciting time to see how they will impact precision medicine and policy in general.