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 2022 Priorities Advocacy Archive Public Policy Initiatives

News Briefs

4/25/2022 - FORCE added its support to an effort spearheaded by SNMMI asking the House Energy and Commerce and Ways and Means Committee Leadership to schedule a hearing on the Facilitating Innovative Nuclear Diagnostics (FIND) Act. 

5/2022 - Joined a coalition letter to the HHS Secretary emphasizing that regulatory reform of the framework for clinical laboratory diagnostics is essential to protect patients and ensure access to innovative, high-quality diagnostic tests.

3/29/2022 - Signed on in support of the Right Drug Dose Now (Right) Act, which will advance utilization of evidence-based pharmacogenomic (PGx) information in clinical practice, advance precision medicine, and improve quality of care.

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