The FDA just gave consumer genetics testing company 23AndMe permission to sell tests for Bloom syndrome–a disease associated with shortened height and an increased cancer risk. This is the first genetic feature the company is legally allowed to test for since the FDA shut down 23AndMe’s genetic analysis service for consumers back in 2013 out of concern for test accuracy. The FDA announcement also gave the test class II status, meaning it was no longer classified as a medical device and is now exempt from pre-market review by the agency.
So is the FDA’s announcement an acknowledgment that 23AndMe is finally on the right track for providing direct-to-consumer genetic testing?
23AndMe can be excused for celebrating: The 2013 ban effectively stonewalled their prime mission to deliver highly detailed health reports to consumers alerting them of their genetic risk for particular conditions and diseases. In addition to concerns over the accuracy of their tests, the FDA was worried that consumers buying the tests would take them as health gospel and pursue rash action. This led the FDA to ban delivery of genetic analysis reports to consumers, which left 23AndMe only able to use customer data to deliver their raw genetic data and benign ancestry reports. This pushed the company to lean heavily on its alternative source of revenue: selling genetic data.
23AndMe’s terms and conditions allow it to sell genetic data in anonymized bulk collections, essentially turning the genetics analysis company into a data broker–and thanks to the 650,000 people who consented to letting 23AndMe use their genetic data for research, 23AndMe has a nigh-unrivaled collection. 23AndMe has partnered with several research institutions, sharing volumes of genetic data to check out connections between particular genes and particular diseases. It’s also partnered with pharmaceutical titan Pfizer, emphasizing (but not completely guaranteeing) the anonymity of user data being made available.
But the FDA has been the only governmental body to outright ban 23AndMe–it’s continued to sell its $99 personalized genetics analysis kit in the United Kingdom and expanded services to Canada last fall. Even if its prime consumer offering has been frozen in the U.S., 23AndMe is still refining its genetic analysis processes abroad.
Is the FDA really going to parse out 23AndMe’s tests one by one? Releasing this first test shows confidence in the accuracy of at least this 23AndMe test, and the company is confident that this is an important stepping-stone that provides them with a regulatory framework to push for approval for future tests, they said in a statement. We’ll just have to see if the FDA goes faster than approving a single test per year.