After releasing a brief statement when the FDA’s decision to block the sale of 23andMe’s home DNA testing kits was made public, the company’s CEO Anne Wojcicki has sent a letter to her customers further explaining their position relative to the ban and the government agency that oversees and regulates medical devices and technologies.
In the letter, sent out to 23andMe registered customers earlier today, Wojcicki begins by reassuring folks that their tech is both solid and trustworthy, and the product of years of development. Accuracy is the central point of the explainer, and she says they remain comfortable with their track record in that regard. This is likely an indirect response to some criticism that surfaced after the letter was made public, suggesting that 23andMe’s test may not be nuanced enough to deliver a full picture associated with risks of contracting certain diseases, including breast cancer.
Wojcicki characterizes the issue with the FDA as part of an ongoing process to clarify how their service is classified, which explores “new territory” for both parties. It’s true that the FDA has never before had to regulate a test that provides general genetic testing beyond just a specific type of disorder. The FDA, for its part, has given 23andMe 15 days to respond to its letter and describe a plan for resolving its issues with the service.
You can see the full text of Wojcicki’s letter pasted below. Clearly, the company is taking the position that it’s providing a service which is accurate to the claims that it makes about what it provides, while the FDA seems worried more about what consumers will do with the info they receive. As with any type of diagnostic information, there’s a huge amount of agency left in the hands of the person being diagnosed, but the FDA seems intent on making sure that 23andMe’s results don’t somehow result in a public that’s misinformed about the risks they face.
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.
Co-founder and CEO, 23andMe
Photo courtesy flickr user kingair42