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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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News Briefs

1/28/2024 - Sent comments to the FL Senate Banking and Insurance Committee in support of SB 932, legislation aiming to expand coverage of high-risk, supplemental breast screenings and diagnostic imaging with no patient cost-sharing.

1/16/2024 - Joined stakeholders in a letter to President Biden asking that he recognize March as National Colorectal Cancer Awareness Month and light the White House blue to honor those we have lost and those fighting this disease.

12/7/2023 - Asked HHS to issue guidance clarifying that “surveillance colonoscopy” after a colonoscopy that required polyp removal is part of screening and that patients should not face out-of-pocket costs for the follow-up procedure.

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