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
8/14/2023 - Joined stakeholders in a letter to the American College of Physicians expressing disappointment with the preventive colorectal cancer screening guidance it published, which conflicts with recommendations provided by the USPSTF, NCCRT, ACS, NCCN and other reputable organizations.
7/21/2023 - Wrote House and Senate leadership, expressing support for increased funding for the Agency for Healthcare Research and Quality (AHRQ) in its staffing and administrative support of the U.S. Preventive Services Task Force (USPSTF) as part of the FY24 appropriations bill.
6/7/2023 - Joined physicians and patient advocacy groups to support California AB 632, which will allow patients to receive prostate cancer screening without a deductible, copayment, or coinsurance for prostate cancer screening, including men over the age of 40 who are at high risk for prostate cancer.
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.