FDA greenlights 23andMe’s request to market direct-to-consumer genetic health risk reports


The U.S. FDA has granted 23andMe the first authorization to market genetic reports on genetic risk for ten conditions, including late-onset Alzheimer’s disease, Parkinson’s disease, celiac disease and hereditary thrombophilia (harmful blood clots), among others.

“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 co-founder, 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.”

23andMe Personal Genome Service submissions for genetic health risk reports were evaluated through the de novo classification pathway, a regulatory process for low- to-moderate-risk medical devices that are first-of-a-kind, for which special controls can be developed. In addition to general controls the process provides a reasonable assurance of safety and effectiveness of the devices. Further, the FDA indicated it will create a class II exemption for 23andMe’s substantially equivalent reports, opening a pathway for the company to release additional genetic health risk reports.

The company will release its first set of new genetic health risk reports including Late-Onset Alzheimer’s Disease, Parkinson’s Disease, Hereditary Thrombophilia, Alpha-1 Antitrypsin Deficiency, and a new carrier status report for Gaucher’s Disease in April, with additional reports to follow. New 23andMe Health + Ancestry Service customers in the U.S. will have access to these reports, while current customers will be notified on their eligibility for receiving the new genetic health risk reports.

The announcement comes on the heels of the FDA’s clearance in February 2015 when 23andMe was granted authorization by the FDA to market the first direct-to-consumer genetic test for Bloom Syndrome under the de novo pathway which enabled the company to bring 35+ carrier status reports directly to its customers. These reports convey inherited risk. Genetic health risk reports, by contrast, convey personal health risk, necessitating a separate FDA review classification pathway.

The analytical testing of the 23andMe genotyping process and the ability to correctly identify the variants in each of the new reports had to meet accuracy thresholds of 99 percent or higher, per the review process.