More than a year after the Food and Drug Administration barred 23andMe from marketing a broad-based genetic testing service, it looks like the FDA plans to shift gears and allow such tests to be sold directly to consumers.
The announcement came in a release late Thursday from the regulator that said it’s authorizing 23andMe to market a specific test to consumers for Bloom Syndrome, a rare inherited disorder associated with short stature and various cancers that often result in death by the mid-20s. The genetic testing company had submitted the test for FDA approval last June.
But the agency then proceeded to lay out broader plans for reversing its stance on direct-to-consumer tests to screen for genetic carriers of diseases. Until now, the FDA had treated such tests as medical devices, which required a much longer and more rigorous approval process for each disease test. Now, the agency says it’s willing to allow these tests to be sold without specific FDA approval. The move is specifically for autosomal recessive diseases that a person who may display no symptoms of the disorder could pass along to offspring.
It’s not yet clear how sweeping the FDA’s move is, and it may not happen all that soon. It still needs to come out with a specific notice of what it intends to require, which will be followed by a 30-day public comment period and then implementation. In a blog post, CEO Anne Wojcicki called the Bloom Syndrome test approval “an important first step [her emphasis] in fulfilling our commitment to return genetic health reports to consumers in the US.”
She also told Bloomberg that she expected to be able to sell the company’s test with some health analysis later this year, with health reports updated as 23andMe gets more approvals for other disease analysis. In a release, the company added, “23andMe will not immediately begin returning Bloom syndrome Carrier Status test results or other health results to customers until it completes the regulatory process for additional test reports and can offer a more comprehensive product offering.”
Still, it’s not yet clear that 23andMe can sell its genetic tests for as wide a variety of diseases all at once as it once did, according to FDA press officer Jennifer Dooren, reached late tonight. …