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

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12/14/2020 - Reached out to Hill leadership requesting that any end-of-year legislative package include a permanent extension of the 7.5% threshold for medical expense deductions. 

12/10/2020 - Joined over 300 national, state and community organizations in a letter to the Biden-Harris Transition Team urging the incoming administration to prioritize healthcare immediately upon taking office and outlining key priorities. 

12/9/2020 - Signed on to a letter asking Congressional leadership to include the Removing Barriers to Colorectal Cancer Screening Act (HR1570/S668) in the year-end legislative package, waiving Medicare coinsurance if polyps are found/removed during a colonoscopy screening.

11/17/2020 - Sent a letter to Texas legislators expressing support for genetic counselor licensure, an important mechanism to help patients and providers identify appropriately trained and qualified genetic counseling professionals.

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