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
4/7/2025 - Joined the Ad Hoc Group for Medical Research and over 500 organizations in recommending at least $51.303 billion for NIH for FY2026, in addition to support for the Advanced Research Projects Agency for Health, representing a 9.0% increase over the final FY2025 funding level.
03/26/2025 - Urged the Senate to protect Medicaid and other critical healthcare programs as it considers the budget reconciliation and potential program cuts.
03/17/2025 - Encouraged congressional leadership to prioritize patient-centered engagement as it crafts healthcare policies in the 119th Congress and ensure that patients don't face unintended consequences due to health policy changes.
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