23andMe which is the leading personal genetics company received 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.
Anne Wojcicki, 23andMe CEO and co-founder said “We believe it’s important for consumers to have direct and affordable access to this potentially life-saving information. We will continue pioneering a path for greater access to health information, and promoting a more consumer-driven, preventative approach to health care.”
23andMe will suggest on three variants in the BRCA1 and BRCA2 genes associated with a significantly higher risk of breast and ovarian cancer in women, and breast cancer in men. The variants may also be associated with an increased risk for certain other cancers. These variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities. About 1 in 40 individuals of Ashkenazi Jewish descent has one of these three variants.
The 23andMe Personal Genome Service® submission for the BRCA1/BRCA2 (Selected Variants) Genetic Health Risk Report was extensively evaluated through the FDA de novo classification pathway, a regulatory process enabling classification and authorization for novel moderate-risk medical devices (FDA authorization # DEN170046). As part of the review process in order to establish safety and effectiveness for this authorization.