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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
9/25/2024 - Sent a letter to members of the Senate Judiciary Committee strongly opposing efforts to advance S. 2140, the Patent Eligibility Restoration Act (PERA), which would allow patents on abstract ideas, laws of nature, and natural phenomena.
9/9/2024 - Signed on to a comment letter encouraging coverage of computed tomography colonography (CTC) procedures and follow-up colonoscopies in the proposed Medicare and Medicaid Program 2025 Physician Fee Schedule (PFS) rule.
8/2/2024 - Responded to an RFI from Representatives DeGette and Bucshon, providing input on the successes, gaps and unmet needs in the 21st Century Cures and CURES 2.0 initiatives, suggesting components for future efforts.
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.