You may soon be able to test your risk for breast cancer from the comfort of your own home.
The FDA will allow genetic testing company 23andMe to give its customers information about their risk for breast cancer, it announced Tuesday. 23andMe's "Health + Ancestry" DNA test purports to detect genetic markers linked to several diseases, including celiac disease, Alzheimer's, and Parkinson's, in addition to other traits like eye color, hair loss, and lactose intolerance. For its breast cancer testing, it focuses on the BRCA1 and BRCA2 genes, as mutations in those genes most often lead to breast and ovarian cancer.
The FDA had previously prevented the company from releasing those results in 2013. Although 23andMe's test is not comprehensive in assessing breast cancer risk, the three mutations of BRCA1 and BRCA2 that it is calibrated to detect are commonly found in the Ashkenazi Jewish population, The Washington Post reported, meaning the test could be especially helpful for people who weren't aware they had Ashkenazi Jewish ancestors to seek preventative options.
However, because 23andMe's test will not detect the most common mutations in the BRCA1 and BRCA2 gene, the exam's potential is limited. As such, the FDA warned in its statement that doctors and their patients should base any medical decisions on more than just a genetic test — especially given that breast cancer isn't always genetic, STAT reported.
Still, Anne Wojcicki, the co-founder of 23andMe, is "thrilled" with the FDA's decision, she told the Post. The move means that patients will soon be able to conduct the test, without a doctor's prescription, at their own convenience. The FDA's decision could additionally pave the way for future tests to become available to consumers without a doctor's orders. Read more at The Washington Post.