This will be the first at-home DNA test for the three BRCA1/BRCA2 gene mutations most common in people of Eastern European descent. The test analyzes DNA collected from a saliva sample and reports whether a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast or prostate cancer.
However, the FDA noted in its Tuesday news release, a negative result doesn’t rule out the possibility that an individual carries other BRCA mutations that increase cancer risk. There are more than 1,000 known BRCA mutations.
“While the detection of a BRCA mutation on this test does indicate an increased risk, only a small percentage of Americans carry one of these three mutations and most BRCA mutations that increase an individual’s risk are not detected by this test,” Donald St. Pierre of the FDA’s Center for Devices and Radiological Health, said. “The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk.”
The National Society of Genetic Counselors echoed St. Pierre’s statement in a blog post and added that "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.”
Breast cancer is the most common cancer in American women and the second-biggest killer, after lung cancer. According to the American Cancer Society, 260,000 women and a few men will be diagnosed with breast cancer in 2018 and nearly 41,000 will die as a result of breast cancer.
A 23andMe spokeswoman said the test will be added to its services “in the coming weeks” with no increase to the current $199 cost, CNN reported.
In 2015, the FDA approved 23andMe’s test for customers to show whether they are carriers of certain disease-carrying genes that could be passed on to their children.
Last year, the company was also granted approval to issue genetic health risk reports.
23andMe CEO and founder Anne Wojcicki thanked the FDA on Twitter Tuesday for their “hard work and progress on innovation.”