23andMe FDA

Landmark decision: FDA Approves 23andMe Genetic Test

23andMe

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 …

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23andMe and the FDA: Perspectives on Warning Letter

23andMe

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 …

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