After the Food and Drug Administration ordered that 23andMe suspend use of its at-home gene testing kits, based on the government organization’s belief that it constitutes a medical device and thus requires further examination and testing before it can be sold. 23andMe followed up that bombshell with the news that it would be working with the FDA to try to resolve the issue, and as a next step it will stop health-related testing altogether.
In a notice posted to its website, 23andMe says it has suspended the sale of its health-focused tests, specifically during the review the FDA is conducting of its health-based claims regarding its product. The company was apparently able to avoid a blanket ban, however, and will still provide new and existing customers with tests that provide ancestry data, and access to raw, uninterpreted genetic data.
The cut off date for access to health-related testing was November 22, 2013, so anyone who bought before that date will still get their results as promised, and continue to have access to that info. They won’t get any new updates regarding health-related results. New customers who purchased after November 22 will get ancestry and raw data, and if all goes well with the ongoing FDA certification process, they’ll be eligible to receive health info in the future. They’re also eligible for a refund, and will receive emailed instructions on how to get one.
There has been a lot of debate about the validity of the FDA’s concerns regarding 23andMe’s service. The genetic testing company has never claimed to make prescriptive judgements regarding user health, but many argue that information it provides about potential genetic illnesses could provoke extreme reactions from customers, including taking preventative steps like advance mastectomies, based on information that could be erroneous or not fully contextualized. Others have argued the FDA is being overly sensitive, and that the data 23andMe provides is innocuous enough on its own, even that which falls into the health category. A good summary of both sides can be found on Hacker News, and 23andMe’s complete letter to website visitors can be found below.
Welcome to 23andMe.
At this time, we have suspended our health-related genetic tests to comply with the U.S. Food and Drug Administration’s directive to discontinue new consumer access during our regulatory review process.
We are continuing to provide you with both ancestry-related genetic tests and raw genetic data, without 23andMe’s interpretation.
If you are an existing customer please click the button below and then go to the health page for additional information. If you are a customer who purchased before November 22, 2013, you will still have access to your health-related results.
We remain firmly committed to fulfilling our long-term mission to help people everywhere have access to their own genetic data and have the ability to use that information to improve their lives.
Upon entering the site, please confirm you understand the new changes in our services.