FDA Approves First Cancer-Spotting DNA Test

By: Rachel Theodorou

On March 6 2018, the FDA approved, with warnings, the first ever breast cancer-spotting DNA test. This test, produced and distributed by California-based company 23andMe, searched for three DNA mutations that are found most commonly in people of Jewish descent. The test “analyzes DNA from a self-collected saliva sample, and the report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer.”

While this may seem like a step in the right direction, the test is able to detect only three out of over 1,000 breast cancer-causing genes, none of which are the most common BRCA1/BRCA2 mutations. Additionally, consumers do not need a doctor’s prescription to obtain and use the test. The National Society of Genetic Counselors stated, “[p]eople shouldn’t take the test without talking to an expert…consumers who test positive for these mutations need to be retested in a clinical setting under the supervision of a medical professional before moving forward with any medical decisions.” The group also opined that anyone who is interested in finding out more about their individualized risk should consult with a genetic counselor.


Maggie Fox, FDA OKs 23andMe home breast cancer DNA test, with warning, NBC News (last visited Mar. 8, 2018), https://www.nbcnews.com/health/health-news/fda-oks-23andme-home-breast-cancer-dna-test-warning-n854206.