Breast cancer test kits by genetic testing company 23andMe just received Food and Drug Administration approval.
The prescription-free test is the first to report on three specific BRCA1 and BRCA2 breast cancer gene mutations, according to the FDA.
By analyzing DNA collected through a saliva sample, the test detects increased risk of developing breast, ovarian or prostate cancer.
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But “it has a lot of caveats,” warned Donald St. Pierre, acting director of the FDA's Office of In Vitro Diagnostics and Radiological Health. The test detects only three out of more than 1,000 known BRCA mutations. That accounts for a small percentage of people. Those most at risk of developing such cancers are of Eastern European Jewish descent.
“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,” he said.
These tests might help with prevention, but cannot diagnose cancer and cannot rule out your chances of getting cancer, 23andMe said.
Still, the company, which already tests DNA for other health risks as well as ancestry, said this cancer test is "a step in the right direction."