23andMe CEO Anne Wojcicki recently elaborated on
the warning letter her company received from the FDA.
Wojcicki stands behind the data 23andMe gives its customers, she wrote in a statement. She says she remains committed to working with the FDA to ensure 23andMe is a trusted consumer product. But she also admitted the company has fallen behind in its responses to the FDA’s requests.
To sum up the warning letter, the FDA has two big problems with 23andMe: 23andMe is selling a medical device that is intended to diagnose diseases without approval from the FDA; and it has failed to prove that it has clinically validated its personal genome service.
(For what it’s worth, anyone worried about losing their data can easily download their own raw data.)
23andMe was started in 2007 with the belief that consumers have the right to get access to their genetic information and that information can help them live healthier lives.
It is absolutely critical that our consumers get high quality genetic data that they can trust. We have worked extensively with our lab partner to make sure that the results we return are accurate. We stand behind the data that we return to customers — but we recognise that the FDA needs to be convinced of the quality of our data as well.
In 2008 we began our dialogue with the FDA. The relationship with the FDA remains critically important to 23andMe.
In July 2012 23andMe submitted its first application for FDA clearance and followed on with another submission at the end of August. We received feedback on those submissions and acknowledge that we are behind schedule with our responses.
This is new territory for both for 23andMe and the FDA. This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future. It will also provide important reassurance to the public that the process and science behind the service meet the rigorous standards required by those entrusted with the public’s safety.
I am committed to making sure that 23andMe is a trusted consumer product. I believe that genetic information can lead to better decisions and healthier lives — a goal that all of us share.
We will provide updates as they become available.