FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

FDA Approves 23andMe’s Home Breast Cancer Testing

March 9, 2018

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.

View today's stories