Policy Archive

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

Genetic Counseling & Testing

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. 

Read our official statement

Take Action Now 2021 Priorities Advocacy Archive Public Policy Initiatives

News Briefs

9/29/2021 - Wrote in support of Paid Family and Medical Leave provisions included in the FY 2022 Budget Reconciliation Proposal and advocated for a universal paid leave program.

9/9/2021 - Joined 131 groups in a letter to Congress outlining recommendations to improve prescription drug affordability in Medicare Part D.

8/23/2021 - FORCE submitted feedback on the VALID Act, legislation that proposes sweeping reform of federal oversight of laboratory-developed tests and in vitro diagnostics.

More