23andMe Test Kit / Hong Chang Bum

Ten genetic health risk reports for direct-to-consumer use by 23andMe have been granted premarket authorisation by the US Food and Drug Administration (FDA) this week. The approval comes after the FDA cracked down on 23andMe in 2013 for selling health-related genetic tests directly to consumers.
As direct-to-consumer (DTC) products, people using 23andMe’s tests do not require a doctor’s approval. These are the first such tests to be authorised by the FDA, and the ruling has also put in place a framework for 23andMe to sell similar tests DTC in the future without submitting them for premarket review, provided they follow FDA safety and efficacy regulations.

“Consumers can now have direct access to certain genetic risk information,” said Jeffrey Shuren, Director of the FDA’s Centre for Devices and Radiological Health, 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.”

Read more: ACMG is Not On Board With 23andMe’s FDA Approval

The initial 10 tests to receive authorisation are tests for Parkinson’s disease, late-onset Alzheimer’s disease, celiac disease, alpha-1 antitrypsin deficiency, early-onset primary dystonia, factor XI deficiency, hereditary haemochromatosis, and hereditary thrombophilia. 23andMe have said that they intend to release the first reports this month to both existing customers, who will be notified of their eligibility, and to new customers who can sign up for $199 (£160).

The FDA has said they are planning to outline similar regulations for other companies hoping to market DTC genetic tests. This ruling exempts 23andMe from future premarket reviews for other health risk tests, but it also indicates that other companies may be able to do the same after submitting the first premarket notification.

“A proposed exemption of this kind would allow other, similar tests to enter the market as quickly as possible and in the least burdensome way, after a one-time FDA review,” the FDA have said.
This isn’t the first time 23andMe and the FDA have worked together to approve DTC testing. 23andMe were able to gain clearance for their Bloom syndrome test in 2015, which opened the way for both 23andMe and other companies to offer a large range of carrier screening tests DTC without the need for premarket review.

The FDA have been very clear in saying that this ruling does not extend to any diagnostic tests that can inform treatment decisions, such as BRCA testing. They have also noted that the approved tests can produce false negatives and false positives and so should not use their results to influence their medical decisions. “Users should consult a health care professional with questions or concerns about results,” the agency said.

This ruling has come at a time when the interest in genomics has been growing within the general population, as seen by the rise in companies like 23andMe. “This is an important moment for people who want to know their genetic health risks and be more proactive about their health,” said Anne Wojcicki, CEO of 23andMe, 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.”