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

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


Newsflash

2/25/2020 - We joined other coalition members in a letter to Congressional leadership urging reauthorization of the PALS and EARLY Acts to ensure continued access to breast cancer education, awareness and screening.

12/17/2019 - A FORCE staff member made comments at the FDA ODAC hearing in favor of olaparib as maintenance therapy for BRCA+ metastatic pancreatic cancer patients.

12/9/2019 - FORCE and 100+ orgs advocated that legislators complete FY20 Defense Appropriations Act negotiations and quickly pass/enact the bill to ensure continued funding of the DoD CDMRP.

12/4/2019 - We wrote South Carolina Senate medical affairs committee members asking that they support genetic counselor licensure in the state.

12/4/2019 - We joined the MedEx Coalition in asking elected officials to co-sponsor the Medical Expense Savings Act, legislation making the 7.5% threshold for medical expense deductions permanent.

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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