23andMe gets FDA's go-ahead to sell genetic health risk tests, opening the door for faster approval for future tests

By Heather Mack
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In a true first, the Food and Drug Administration is allowing 23andMe to sell its direct-to-consumer genetic test kits that provide information about an individual’s risk to certain diseases such as Alzheimer’s or Parkinson’s disease.

23andMe’s $199 genetic tests are available with the FDA’s blessing nearly three and a half years after the agency first ordered 23andMe to immediately stop selling its testing service for genetic risks, citing a lack of evidence to support the efficacy of tests (although the company was allowed to continue selling its popular ancestry tests it has offered since 2007). That led 23andMe to re-launch a toned-down version in late 2015, which gave consumers reports about their “carrier status” of certain conditions but not a genetic health risk. In the meantime, they didn’t avoid the FDA, but doubled down on their clinical validation to finally land the agency’s approval.

“This is an important moment for people who want to know their genetic health risks and be more proactive about their health,” Anne Wojcicki, 23andMe CEO and cofounder, said in a statement. “The FDA has embraced innovation and has empowered individuals by authorizing direct access to this information. It is a significant step forward for 23andMe and for the adoption of personal genetics.”

The Genetic Health Risk (GHR) test works by isolating DNA from a saliva sample, then analyzing it for over half a million genetic variants. The presence or absence of some of these variants can be associated with an increased risk for developing 10 conditions including Parkinson’s disease, late-onset Alzheimer’s, Celiac disease, and several blood, organ or tissue disorders.

“Consumers can now have direct access to certain genetic risk information,” Dr. Jeffery Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “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.” 

Not only does the clearance legitimize 23andMe’s current offering, it also opens the door for future tests from the company to hit the market faster as it will no longer be a test-by-test process: the FDA stated it intends to exempt additional 23andMe GHR tests from premarket review, and that allowance extends to other companies in the consumer genomics space. After a one-time FDA review, this proposed exemption “would allow other, similar tests to enter the market as quickly as possible and in the least burdensome way,” the agency said in a statement.

“The special controls describe the testing that 23andMe conducted to demonstrate the performance of these tests and clarify agency expectations for developers of other GHRs,” Shuren said in a statement. “By establishing special controls and eventually, a premarket review exemption, the FDA can provide a streamlined, flexible approach for tests using similar technologies to enter the market while the agency continues to help ensure that they provide accurate and reproducible results.”

Diagnostic tests, such as those that are used as the sole basis for major treatment decisions like a genetic test for BRCA, are still off the table for now. However, 23andMe’s trailblazing on GHR could bring a much-needed dose of legitimacy to the rapidly-expanding consumer genomics space. Some personal genomics companies are taking it seriously through partnerships with medical institutions (such as Helix’s collaboration with Mount Sinai), but others with questionable veracity have emerged  – such as those purporting their saliva-based DNA tests can provide insights into everything from how people should exercise and sleep to what wine they should drink. Geneticists contend we’re far from that level of understanding about personal genetics, but since these companies are stopping short of making health claims, they are outside the purview of the FDA.

In the time during 23andMe’s long and complicated tangle with the FDA, research and understanding around genetics has increased tremendously. What’s more, the data the company has on some 2 million customers is particularly valuable for its own internal research programs. The company partnered with Genentech in 2015 to target therapeutics for Parkinson’s, teamed up with Apple in March 2016 to bring genetic data into ResearchKit, and just recently started working with big data fertility company Celmatix .