Blog Post

23andMe shuts down health-related genetics testing to work with FDA

After receiving a cease and desist from the FDA and getting slapped with a class action law suit, genetic testing startup 23andMe has announced via blog post that it will not complete health-related reports on kits purchased on or after November 22 — the date the FDA posted its complaint letter — until it’s reached regulatory approval. The company is offering a full refund to those who don’t have access to their genetic reports, as its unclear when (and how) the service will come back. 23andMe CEO Anne Wojcicki continues to stand by the accuracy of her company’s tests, and the firm continues to issue ancestry-related and raw-data reports.

It’s a big blow to the disruptive company, which has made a name for itself (and heavily advertised) its accuracy in identifying risk factors for diseases like cancer, Alzheimer’s and celiac disease. But it shows that regulations still apply to Silicon Valley — whether they’re wanted or not.

Update: To clarify, 23andMe has only ceased its health-related reports related to its genetic testing kit, not its entire line of services. Users that are still interested in purchasing a kit for ancestry or raw-data reports can do so. The report above has been ammended to stress that.

4 Responses to “23andMe shuts down health-related genetics testing to work with FDA”

  1. Mary K.D. D'Rozario

    Headline and article VERY misleading. 23andme will not offer health-related reports- they are far from “shut down.” They still do the testing and provide the raw data to the user. Unfortunately it is now a cumbersome process for the user to get the health information out of the data.

  2. Your headline and summary are not accurate. 23andMe will continue offering genetic tests and results to consumers for $99 a pop. What they will stop doing is providing health analysis reports or interpretations based on the results. For users that completed tests in the past