Posted by Michael Wonder on 08 Mar 2018
23andMe granted first FDA authorisation for direct-to-consumer genetic test on cancer risk
6 March 2018 - Authorisation allows 23andMe to report on BRCA1- and BRCA2-related genetic risk for breast, ovarian and prostate cancer.
23andMe today received the first-ever FDA authorisation for a direct-to-consumer genetic test for cancer risk. The authorisation 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.
23andMe will report 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. Women with one of these variants have a 45-85% chance of developing breast cancer by age 70.
