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 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's 2015 FDA authorization was for Bloom Syndrome and other Carrier Status reports, and we have continued to release additional Carrier Status reports over time.
Since then, 23andMe has continued to seek FDA authorization to offer new types of 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. Since then, we have released a number of additional genetic health risk reports.
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 in the BRCA1 and BRCA2 genes known to be associated with higher risk for breast, ovarian prostate, and pancreatic cancer. This report is included in ourHealth + Ancestry Service. In August 2023, 23andMe received clearance to add 41 additional BRCA1/2 variants to the report, for a total of 44 variants. Many of these additional variants are most common in populations traditionally underserved by genetic testing, including the African American, Hispanic/Latino, and Asian communities.
In October 2018, 23andMe received the first FDA authorization for direct-to-consumer genetic reports on pharmacogenetics, which provide information on how DNA may influence the processing of certain medications. We launched with three Pharmacogenetics reports focused on three genes: CYP2C19, DPYD, and SLCO1B1. Since then, 23andMe has received two additional clearances related to pharmacogenetics: One in August 2020 for two CYP2C19-related medication insights — on citalopram (used to treat symptoms of depression) and clopidogrel (used to treat certain heart conditions) — and one in July 2023 for an SLCO1B1-related medication insight on simvastatin, which is used to treat high cholesterol.
In January 2019, 23andMe received FDA clearance to report on the two most common genetic variants linked to 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 in the MUTYH gene included in this clearance are Y179C and G396D..
In January 2022, 23andMe received FDA clearance to report on a form of hereditary prostate cancer caused by the G84E variant in the HOXB13 gene. 23andMe+ Premium and 23andMe+ Total Health members have access to this report.