On Aug. 31, 2023, the U.S. Food and Drug Administration (FDA) cleared for marketing the updated 23andMe Personal Genome Service (PGS) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants). It is a direct-to-consumer test that reports selected BRCA1/BRCA2 genetic variants from human saliva collected from individuals 18 years or older. The test was updated to add 41 BRCA1/BRCA2 variants to the previously authorized test.

The test analyzes DNA from a self-collected saliva sample and generates personalized reports that describe if the genetic variants detected in that sample are associated with an increased risk of developing breast and ovarian cancer and may be associated with an increased risk for prostate cancer, pancreatic cancer, and potentially other cancers.