The three gene mutations are most common in people of Ashkenazi (Eastern European) Jewish descent, but are not the most common BRCA1/BRCA2 mutations in the general population.
"It's better to find out sooner than later", said Charmaine Tyson, a two-time breast cancer survivor.
It noted that the test only checks for three of more than 1,000 known BRCA mutations and that a negative result does not rule out increased cancer risk. Due to the mentioned caveats, the agency indicated that patients should not exclusively rely on this test, nor should the test be used to determine a cancer treatment.
"There are other genes besides BRCA1 and BRCA2 for breast cancer, and there are lots of other mutations on BRCA1 and BRCA2 that aren't being tested".
The FDA approved the first test that people can get without a doctor to see if they carry a genetic mutation that increases their risk for cancer.
BRCA1 and BRCA2 are DNA fix genes.
The three mutations detected by the test occur in about 2 percent of Ashkenazi Jewish women, but only 0 to 0.1 percent of other ethnic groups, according to the U.S. National Cancer Institute.
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Statistics show roughly one in eight women will develop invasive breast cancer over the course of their lifetime.
BRCA mutations are not the only genetic mutation that raise the risk of breast or ovarian cancer. That accounts for a small percentage of people.
In a reversal of fortune for 23andMe, the US Food and Drug Administration (FDA) has granted the company the first-ever authorization for direct-to-consumer genetic testing for cancer risk without a prescription.
And the FDA said no doctor or patient should use the test as a basis for deciding treatment, "including anti-hormone therapies and prophylactic removal of the breasts or ovaries".
Genetic testing powerhouse 23andMe announced today that it's officially received the FDA go-ahead to launch a direct-to-consumer testing kit for genes linked to various forms of cancer.
Along with the approval, the FDA is setting up special controls to ensure the test's accuracy and performance, the agency said.