Home » FDA Approves 23andMe’s Home Breast Cancer Testing
FDA Approves 23andMe’s Home Breast Cancer Testing
Devices Submissions and Approvals
The FDA approved 23andMe’s at-home screenings for three breast cancer mutations.
Women who carry one of the three BRCA1 and BRCA2 gene mutations are at substantially increased risk for developing breast and ovarian cancer.
The genetic testing company will report the test results as part of its Health and Ancestry product.