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

Take Action Now 2021 Priorities Advocacy Archive Public Policy Initiatives

News Briefs

3/31/2021 - Expressed support for legislation (S.5355/A.2151) that would establish genetic counseling as a licensed profession in the state of New York.

3/16/2021 - Signed on in support of the Medicare Multi-Cancer Early Detection Screening Coverage Act of 2021 (H.R. 1946), which will give CMS authority to cover blood-based multi-cancer early detection tests and future test methods (like urine or hair tests), once approved by the FDA.

2/17/2021 - In a letter to President Biden, underscored the urgency of prioritizing access to the COVID-19 vaccine for patients with active cancer and survivors of cancer.

2/4/2021 - Joined a group of 75 orgs in a letter to HHS expressing concern that new Medicare Payment Modernization models proposed by the prior administration could jeopardize access to medically necessary prescription drugs and harm patients with serious illnesses.

More