23andMe Scores FDA Nod for First DTC Genetic Test on Cancer Risk

Regulatory NewsRegulatory News | 06 March 2018 |  By 

Staying ahead of the curve on direct-to-consumer (DTC) genetic health risk (GHR) assessments, 23andMe became the first company with US Food and Drug Administration (FDA) marketing authorization for three cancer-associated variants.

This first-ever FDA authorization allows for 23andMe customers to obtain information on three variants on the BRCA1 and BRCA6 genes, “known to be associated with higher risk for breast, ovarian, and prostate cancer,” the company said, adding that these reports will be made available in the coming weeks.

According to FDA, the mutations the report tests for are most common in people of Ashkenazi (Eastern European) Jewish descent.

Donald St. Pierre, acting director of FDA’s Office of In Vitro Diagnostics and Radiological Health, said the test has “a lot of caveats” as it only detects three out of upwards 1,000 known BRCA mutations.

“Only a small percentage of Americans carry one of these three mutations and most BRCA mutations that increase an individual’s risk are not detected by this test,” Pierre said. He also advised against using the test as a substitute for “cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk.”

FDA evaluated the submission for the selected genetic variants through its De Novo classification pathway and this is 23andMe’s third De Novo authorization.


The California-based genetics testing company has aided FDA in recent years with establishing a new regulatory approach for GHR tests. Its new marketing authorization is consistent with those previously received as it also became the first company with an FDA nod for DTC tests designed to identify risks for 10 diseases, such as Parkinson’s disease and late-onset Alzheimer’s disease, last April.

Under the new FDA approach, GHR testing systems were put in the Class II with special controls category last November, and a proposed premarket review exemption would allow developers to be subject to a one-time FDA review to mitigate risks of false negatives and positives.

The move came as more and more consumers are embracing the possibility of learning more about risks for developing certain diseases, FDA Commissioner Scott Gottlieb previously said. The new approach “builds on the important lessons” learned from “FDA’s authorization of the first GHR and carrier screening tests sold directly to consumers” from 23andMe.  

 23andMe FDA


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