Over the last few months we’ve heard from many of you asking about where 23andMe stands in the FDA authorization process, so here is the latest.
To remind you, back in November the FDA ordered 23andMe to stop returning health results to new customers until we completed the agency’s regulatory review process. 23andMe quickly complied.
“My main priority is resolution with the FDA,” our CEO and co-founder Anne Wojcicki said recently.
Despite 23andMe’s intense attention on this regulatory process, navigating it will take time.
This means all 23andMe customers who purchased on or after November 22, 2013, still do not have access to health results, nor will they in the immediate future. We are working with the FDA so that we can return a subset of health reports, but we don’t know how long that process might take. We do not have a timeline as to which health reports might be available in the future or when they might be available.
For now, new customers have access to their ancestry results and their uninterpreted genetic data. Customers who purchase 23andMe now should do so with the understanding that health results are not available to them. Again, we do not yet have a timeline for when they may be available. We are doing everything we can to work through this process and return to providing all 23andMe customers access to genetic health information.
In that effort, 23andMe scientists and executives have met and communicated directly with FDA officials on a number of different occasions over the last few months. Getting this right is important for everyone involved.
We will continue to be as transparent about the process as we can, and give updates when appropriate.
We remain disappointed that we can not provide you, our customers, with health reports at this time but we remain committed to our mission of empowering individuals with their genetic information.