On March 6, 2018, 23andMe, Inc. received the first-ever FDA authorization for a direct-to-consumer genetic test that analyzes gene mutations to help predict a subject’s risk of developing specific cancers. 23andMe already sells diagnostic kits by mail that determine a variety of gene profiles from a consumer. This FDA authorization allows 23andMe to supplement the results from those diagnostic tests to also include diagnostic results relating to a consumer’s predicted susceptibility to certain cancers at home without speaking to a doctor. The approved genetic test will screen for three mutations in the BRCA1 and BRCA2 genes that are known to be associated with a higher risk for breast, ovarian and prostate cancer.
The new test, called the 23andMe Personal Genome Service (PGS) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants), was evaluated through the FDA de novo classification pathway. 23andMe demonstrated greater than 99% concordance to Sanger sequencing and yielded greater than 99% reproducibility and repeatability.
The FDA approval permits 23andMe to report the cancer diagnosis results as part of its $199 Health + Ancestry Service. This service utilizes DNA gathered from saliva samples to give consumers information on their families’ countries of origin and genetic health profile. New and existing Health + Ancestry Service customers who were genotyped on 23andMe’s most recent platforms will have access to reports on the three mutations in the coming weeks. Customers can choose whether or not to receive the new cancer diagnosis information when they sign up for the Health + Ancestry Service from 23andMe.