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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 BECOME AN ADVOCATE 2022 Priorities Advocacy Archive Public Policy Initiatives

News Briefs

12/6/2022 - Joined a broad range of stakeholders to urge Appropriations leaders to pass the FY23 Omnibus spending bill, and to include boosted funding for the National Institutes of Health (NIH) and our nation’s other research agencies.

11/28/2022 - Asked congressional leadership to include the Access to Genetic Counselor Services Act (H.R.2144/S.1450) in a year-end legislative package so that Medicare beneficiaries can better access genetic counseling services.

11/21/2022 - Joined the Defense Health Research Consortium in encouraging congressional leaders to enact the FY23 Defense Appropriations Act, to ensure full funding of the Defense Health Research Programs, including the Congressionally Directed Medical Research Programs (CDMRP).

11/2/2022 - Urged congressional leaders to prioritize the Metastatic Breast Cancer Access to Care Act (H.R.3183/S.1312), which eliminates waiting periods for SSDI benefits and for Medicare coverage for individuals with metastatic breast cancer.

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