FDA orders 23andMe to halt sales of its its Saliva Collection Kit and Personal Genome Service

November 26, 2013

(credit: 23andMe)

The FDA has told 23andMe, Inc., the Google-backed DNA analysis company cofounded by Anne Wojcicki, to halt sales of its Saliva Collection Kit and Personal Genome Service (PGS).

In a letter, the FDA said the company was acting “without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act)….”

“Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses [that] have not been classified and thus require premarket approval or de novo classification.”

“We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission,” 23andMe responded in a statement. “Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”

With more than 500,000 genotyped customers, 23andMe enables individuals to gain deeper insights into personal ancestry, genealogy and inherited traits. It offers $99 saliva-testing kits that customers can use at home and then send to the company for reports on how they might be at risk for a range of inherited health conditions and how they are likely to respond to certain drugs.

Dear 23andMe customers,

I wanted to reach out to you about the FDA letter that was sent to 23andMe last Friday.

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 recognize that the FDA needs to be convinced of the quality of our data as well.

23andMe has been working with the FDA to navigate the correct regulatory path for direct-to-consumer genetic tests. This is new territory, not just for 23andMe, but for the FDA as well. The FDA is an important partner for 23andMe and we will be working hard to move forward with them.

I apologize for the limited response to the questions many of you have raised regarding the letter and its implications for the service. We don’t have the answers to all of those questions yet, but as we learn more we will update you.

I am committed to providing each of you with a trusted consumer product rooted in high quality data that adheres to the best scientific standards. All of us at 23andMe believe that genetic information can lead to healthier lives.

Thank you for your loyalty to 23andMe. Please refer to our 23andMe blog for updates on this process.

Anne Wojcicki
Cofounder and CEO, 23andMe

23andMe | “23andMe provides an update regarding FDA’s review
December 5, 2013 | Anne Wojcicki, Coufounder and CEO, 23andMe

After discussion with officials from the Food and Drug Administration today, 23andMe will comply with the FDA’s directive and stop offering new consumers access to health-related genetic tests while the company moves forward with the agency’s regulatory review processes.

23andMe has been giving consumers access to health information for six years and is committed to finding the right regulatory path for our customers. 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. Our goal is to work cooperatively with the FDA to provide that opportunity.

We also want to make clear that we stand behind the data we have generated for customers. Our lab partner adheres to strict quality standards that are part of the Clinical Laboratory Improvement Amendments of 1988 — known as CLIA.

These are the same standards used in the majority of other health and disease-related tests. We decided several years ago to comply with CLIA guidelines to be consistent with other types of laboratory testing and to assure customers about the quality of data.

As we work with the FDA to get clearance, there will be some significant changes to the site. Customers who purchased kits on or after the FDA’s warning letter of November 22nd will not have access to health-related results.

Those customers will have access to ancestry-related genetic information and their raw data without 23andMe’s interpretation of that data. They may receive health-related results in the future, depending on FDA marketing authorization.

Customers who purchased kits before November 22, 2013 will continue to have access to all the reports they’ve always had.

This is clearly a much different service than in the past, so we are offering customers who purchased kits on or after November 22, 2013 a full refund if they wish. Those customers will get an email from 23andMe with details on the refund policy. Eligible customers who do not receive an email are encouraged to check their spam email folders for the email with their personalized instructions or contact our Customer Care Team.

Research is and will continue to be a significant priority for the company. The 500,000+ customers we have today have given us more than 250 million survey data points. You, our customer, have powered an incredibly important crowd-sourced research database that I believe can have a significant impact on the pace of discoveries and cures. We will continue our Parkinson’s, sarcoma, MPN and African American research projects and plan to launch more communities in 2014.

23andMe will also continue educational efforts to consumers, physicians and other health providers as we believe genetics will be an increasingly important part of all of our lives.

Finally, I want to say thank you to our customers for your support and your stories. Many of you have written in about how 23andMe has changed your life. It is rewarding for me and all the employees at 23andMe to serve our customers. I am committed to 23andMe and committed to being a pioneer in the genetics revolution.

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