California's 23andMe has capitulated to the FDA, agreeing to regulators' demands to stop selling all health-related genetic tests while it submits them for a formal regulatory review.
CEO Anne Wojcicki addressed the company's decision in an extensive blog post on 23andMe's website, noting that it comes six years after the company's tests first hit the market.
"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 future," she wrote. "Our goal is to work cooperatively with the FDA to provide that opportunity."
Regulators win big here. They've essentially made an example of one of the pioneering and now most prominent direct-to-consumer DNA testing companies in an ongoing bid to assert greater regulatory control over tests that appear to make diagnostic-related health claims. Executives dug in at first, in the wake of the FDA's scathing Nov. 22 warning letter that slammed the company for its delays in submitting to the approval process. The FDA also demanded the tests be taken off the market until they can be formally reviewed and approved in a bid to treat the tests as formal medical devices as defined by the law.
At first, 23andMe only pulled advertising, but its complete reversal is pretty stunning, considering the company strongly insisted its tests were for "research and educational purposes only."
23andMe's Dec. 5 announcement explained it will follow the FDA's directive for all consumers who purchased the company's Personal Genomic Service saliva-based tests on or after Nov. 22. Those customers can only gain access to ancestry-related genetic information and raw genetic data, minus interpretation. If they're unhappy with the changes, the company will issue a refund. Research involving 23andMe's genetic and phenotypic database will also continue. This isn't total capitulation, however: Customers who snatched up the kits before Nov. 22 can still get access to their full health-related results.
Even in pledging to work with the FDA, Wojcicki still stood strongly behind her company's tests.
"We want to make clear that we stand behind the data we have generated for our customers," she wrote in her blog posting, noting that the company works with a CLIA-certified lab, following 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 the data. Our testing has shown a greater than 99.9% accuracy rate," Wojcicki noted on a slightly defiant note.
23andMe had actually tried to work with the FDA before. In July 2012, the company began the process to seek 510(k) clearance for several of its genetic tests. But Wojcicki acknowledged in the wake of its Nov. 22 FDA warning letter that it had fallen "behind schedule" in its FDA interactions.
In retrospect, 23andMe should have seen this coming. Back in 2010, the FDA determined it would regulate genetic tests that make health claims the same way it handles medical devices. A number of genetic testing companies received letters at that time, including 23andMe, informing them of the regulatory change.
23andMe, which launched in 2006, must also deal with a new class-action lawsuit alleging it misled customers by selling genetic tests with no real scientific value. Plaintiffs are seeking at least $5 million in damages.