[Image courtesy of 23andMe]
The de novo premarket review authorization, announced April 6, also included celiac disease, which results in the inability to digest gluten; alpha-1 antitrypsin deficiency, which raises the risk of lung and liver disease; early-onset primary dystonia, a movement disorder; factor XI deficiency, a blood clotting disorder; Gaucher disease type 1, a disorder involving organs and tissue; glucose-6-phosphate dehydrogenase deficiency, also known as G6PD, a red blood cell condition; hereditary hemochromatosis, an iron overload disorder; and hereditary thrombophilia, a blood clot disorder.
In providing the authorization to 23andMe, FDA also set up a new one-time review process to allow genetic testing companies to get their products to consumers as quickly as possible. 23andMe, for example, won’t need to seek authorizations for additional tests to add to its $199 health and ancestry service, now that it has received the first authorization.
“Consumers can now have direct access to certain genetic risk information. But it is important that people understand that genetic risk is just one piece of the bigger puzzle, it does not mean they will or won’t ultimately develop a disease,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a news release.
23andMe’s win with FDA marks a major turnaround from late 2013, when 23andMe seemed to be stumbling in its goal of bringing affordable genetic health risk tests to the masses. FDA had slapped the Silicon Valley–based company with a warning letter, accusing it of failing to provide requested information about its products. The agency ordered 23andMe to stop selling health-related DNA tests.
Since then, CEO Anne Wojcicki made cooperation with FDA a top priority. FDA authorized 23andMe to add some carrier status tests to its ancestry test offerings in 2015. Now the company is back selling tests for genetic predisposition to certain diseases. In the process, 23andMe helped set a standard with FDA for how the agency will handle genetic testing going forward.
FDA has now established criteria called special control that clarify the agency’s expectations in assuring the tests’ accuracy, reliability and clinical relevance. Now that 23andMe has met the special controls, along with general controls providing reasonable assurance of safety and effectiveness of its genetic health risk tests, it is exempt from having to submit additional tests for FDA premarket review. Other genetic health risk test makers will also be able to receive an exemption after submitting their first premarket notification.
For her par, Wojcicki tells National Public Radio’s Marketplace that her 11-year-old company kind of feels like a startup again, now that it has received the FDA authorization. Wojcicki told the radio program that 23andMe’s goal is to not only empower consumers with genetic health information but to also use their collective genetic information to further research:
“Well, I think that there’s two core elements of our company. One is that we’re all about the consumer and empowering the consumer with information about them and helping them understand what to do with that information and what are the next steps they could do. And the second aspect is this idea that you’re going to benefit from the human genome. So, we ask customers if they want to consent for research, and over 85 percent of our customers actually do consent. And I think that’s part of what we’re trying to do is encourage people to say one of the most valuable things you have is your data, but it’s really most valuable in a collective sense, if we all come together. And we’re going to be the ones who are really understanding the gene and environment interaction and what you can do to change your behavior, and hopefully also making discoveries in therapeutics and hopefully curing diseases.”
Here’s the full Marketplace interview with Wojcicki:
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