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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
7/2/2024 - Joined more than 50 organizations in submitting feedback on the draft guidance for the second cycle of the Medicare Drug Price Negotiation Program, which will impact drug pricing as well as innovation.
5/14/2024 - Urged the House and Senate Appropriations Committees to create a Colorectal Cancer Research Program within the Department of Defense Congressionally Directed Medical Research Programs.
4/29/2024 - Sent the Administrator of the Centers for Medicare & Medicaid Services (CMS) feedback and recommendations on its Medicare Advantage and Prescription Drug Programs: Part C and Part D Medicare Prescription Payment Plan Model Documents.
Related Resources
- Visit the How to Get Testing section of our website for criteria for genetic testing and information on finding a cancer genetics expert.
- FORCE's toll-free helpline: 866-288-RISK, ext. 704, can connect you with a volunteer board-certified genetic counselor who can answer general questions about genetic testing and hereditary cancer and help you find a genetic counselor near you.
- FORCE Peer Navigator Program will match you with a volunteer who has undergone genetic counseling and can help you navigate resources to find a genetic counselor near you.