Advocacy

FORCE advocates for families facing hereditary breast and ovarian cancer in areas such as access to care, research funding, insurance, and privacy.

Advocacy > Issues > FDA Approves New Direct-to-Consumer Genetic Test for 3 BRCA Mutations


Newsflash

9/3/2019
We joined over 50 orgs representing millions of patients, advocates, caregivers, researchers, and physicians to express support for appointment of Norman Sharpless as FDA Commissioner.

7/26/2019
FORCE is supporting legislation (H.R. 4078) to reauthorize and increase funding for the Breast Cancer Education and Awareness Requires Learning Young Act (EARLY) Act.

6/27/2019
We played a lead role in drafting coalition comments on the FDA's proposed mammography guideline updates.

6/21/2019
FORCE recommendations regarding genomics were accepted and will be integrated into the Healthy People 2030 objectives.

6/3/2019
Today, the FDA announced a new pilot program called Project Facilitate to assist oncologists in requesting access to unapproved therapies for cancer patients.

FDA Approves New Direct-to-Consumer Genetic Test for 3 BRCA Mutations

Genetic Testing & Counseling

Overview

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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