FDA Gives Green Signal To 23andMe To Sell Test Kits For Rare Genetic Disorder
The Food and Drug Administration (FDA) has re-allowed the broad-based genetic testing service, 23andMe, to start selling directly to customers – but for one specific test only, of the deadly Bloom Syndrome.
FDA had prohibited 23andMe from selling the health reports, in November 2013, on grounds of the company violating the Federal Food, Drug and Cosmetic Act (the FD&C Act). So this grant by the FDA is obviously a big step in 23andMe’s favor.
The announcement came late this Thursday from the authority, saying that it was permitting 23andMe to market a particular test to consumers for Bloom Syndrome, which is a rare “inherited disorder characterized by short stature, sun-sensitive skin changes, an increased risk of cancer, and other health problems” which often proves fatal by the mid-20s. 23andMe had submitted the test for the disorder last June to FDA for approval.
“The FDA believes that in many circumstances it is not necessary for consumers to go through a licensed practitioner to have direct access to their personal genetic information,” said Alberto Gutierrez, director at FDA’s Center for Devices and Radiological Health.
“Today’s authorization and accompanying classification, along with FDA’s intent to exempt these devices from FDA premarket review, supports innovation and will ultimately benefit consumers.”
This means that the agency is now moving past treating these tests as medical devices, which require a lot of time in the approval process. Now, the agency has allowed 23andMe to sell these tests without specific FDA approval.
The step is being taken specifically for autosomal recessive diseases, which are diseases that show no signs in the person because of being embedded in a recessive allele, but have a greater chance of being transferred to the next generation as dominant.
However, there is no clear stance regarding how much extensive this move is by the FDA, as it still needs a notice of its requirements for the process, which will then have to be followed by a 30-day public comment period and then would come the implementation at last. In a blog post, CEO Anne Wojcicki called the Bloom Syndrome test approval “an important first step in fulfilling our commitment to return genetic health reports to consumers in the US.”
The Silicon Valley originated startup expects to be able to sell its tests with some health analysis later this year, with future submissions “based on the learnings we gained during the Bloom syndrome review process,” the company noted. “Because this process was successful, we may be allowed to provide some reports without premarket review and to submit some future submissions through the standard 510(k) pathway.”
In a press release, it 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.”