23andMe surrenders to FDA: Rebrands testing kits, stops offering genetic analysis

At 23andMe, genetic analysis is out, but ancestry info and raw data are still very much in.

Last week, the U.S. Food and Drug Administration ordered the company to halt sales of its Personal Genome Service, which regulators say still needs approval as a medical device.

Now, 23andMe is complying with the order, but only as much as it really needs to. Rather than completely suspend sales of its testing kit, 23andMe says it will only stop giving customers analysis based on their data. Or, as the company puts it, customers will get “raw genetic data without interpretation.”

More interesting is how the company has rebranded the testing kit to focus on ancestry info, not health and wellness. What used to look like this:

Now looks like this:

Core to the FDA’s concerns is that people who buy 23andMe’s kits could act on the company’s data analysis by undergoing unnecessary procedures — like MRIs and mastectomies — or feel a false sense of complacency towards their health risks, which is just as bad. In other words, it’s the analysis, not the raw data, that’s gotten 23andMe into the most trouble. 

The company isn’t entirely contrite, though. In the notice posted to its website, 23andMe says its committed to its mission to give people access to their own genetic data, which it says can improve lives.

“I am highly disappointed that we have reached this point and will work hard to make sure consumers have direct access to health information in the near future,” CEO Anne Wojcicki wrote in a blog post last night.

This might be bigger than 23andMe, though. Wojcicki previously hinted that she sees her company’s situation as a landmark case for the future of direct-to-consumer genetic testing as a whole.