January 17, 2021

The Niche

Trusted stem cell blog & resources

23andMe FDA

1 min read

23andMe CEO, Anne Wojcicki, just emailed 23andMe customers (me included) with the big news that the FDA has approved the company to offer Bloom syndrome carrier status reporting. As Wojcicki points out, this is the first time ever that the FDA has granted authorization of a direct-to-consumer genetic test. This is a huge deal. Why Bloom syndrome? Why now? What else is coming? A lot of interesting questions. Update: Here is the FDA statement on the authorization including this key requirement: “If sold over …Read More

4 min read

What’s the deal with this week’s FDA Warning Letter to 23andMe? First some background. I’m a researcher who studies stem and cancer cell genomics and epigenomics. I’m also a human being who has battled prostate cancer and is curious about my genome. With this background, I decided some time ago to take the plunge and experience what 23andMe has to offer in the way of personal genomics analysis. I thought of it as an experiment. I contacted them with my interest and background. We agreed to …Read More