Policy Archive
FDA Approves New Direct-to-Consumer Genetic Test for 3 BRCA Mutations

On March 6, 2018, the Food and Drug Administration (FDA) announced approval of a new direct-to-consumer genetic test for three BRCA mutations most commonly found in people with Ashkenazi Jewish (Eastern European) ancestry, often referred to as founder mutations.
With thousands of known BRCA mutations, 23andMe's "Personal Genome Service Genetic Health Risk (GHR) Report for BRCA1/BRCA2 (Selected Variants)" provides consumers with an extremely limited snapshot of potential hereditary cancer risk.
News Briefs
02/25/2025 - Called on Congress to prioritize robust funding for the National Institutes of Health (NIH) in the FY2025 appropriations bill and to preserve protections against reimbursement cuts for NIH grantee Facilities and Administrative costs.
02/24/2025 - Joined hundreds of orgs in thanking lawmakers for advancing the availability of healthcare through telehealth and asking congressional leaders to establish permanent or long-term telehealth access.
01/30/2025 - Urged the President to recognize March 2025 as National Colorectal Cancer Awareness Month and to light the White House blue to honor those we have lost and those fighting this disease.
Stay up to date on hereditary cancer information.