23andMe and the FDA

In 2013, 23andMe received a warning letter from the US Food and Drug Administration (FDA) to discontinue marketing its health-related genetic tests in the United States until it completed the agency’s regulatory review process. We complied with that request and subsequently, and until October 2015, provided only Ancestry Reports and raw data to customers who purchased the service.

A new 23andMe experience launched in October 2015. The new 23andMe experience reflected almost two years of work with regulators, our scientists, medical experts, and product designers. The result is the first direct-to-consumer test available directly to individuals in the United States that includes reports that meet FDA requirements for being scientifically and clinically valid. 23andMe will continue to seek FDA authorization to offer new reports.

On April 6, 2017, 23andMe was granted authorization by the FDA to market Late-Onset Alzheimer's Disease, Parkinson's Disease and Hereditary Thrombophilia genetic health risk reports along with other reports. We released the 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.

On March 6, 2018, 23andMe received the first-ever FDA authorization for a direct-to-consumer genetic test for cancer risk. The authorization allows 23andMe to provide customers, without a prescription, information on three genetic variants found on the BRCA1 and BRCA2 genes known to be associated with higher risk for breast, ovarian and prostate cancer. Eligible new and existing 23andMe Health + Ancestry Service customers that were genotyped on the company’s most recent platforms now have access to this report.

In January 2019, 23andMe received FDA clearance to report on the two most common genetic variants influencing what is called MUTYH-associated polyposis (MAP), a hereditary colorectal cancer syndrome. Eligible new and existing 23andMe Health + Ancestry Service customers that were genotyped on the most recent genotyping platforms (V4 or V5) now have access to this report. The specific variants on the MUTYH gene included in this clearance are Y179C and G396D. Learn more about this report.