The news and stories that matter, delivered weekday mornings. For the first time, the agency authorized 23andMe's test for 3 BRCA1/BRCA2 breast cancer mutations, which are most common among Ashkenazi Jews.
"It's better to find out sooner than later", said Charmaine Tyson, a two-time breast cancer survivor.
The U.S. Food and Drug Administration (FDA) has cleared 23andMe to launch a direct-to-consumer DNA test for gene mutations connected to various forms of cancer. "This means a negative result does not rule out the possibility that an individual carries other BRCA mutations that increase 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.
Breast cancer is the second-biggest cancer killer of American women, after lung cancer. "The test should not be used as a substitute for seeing your doctor for cancer screening or counseling on genetic and lifestyle factors that can increase or decrease cancer risk".
BRCA1 and BRCA2 are DNA fix genes. She works for and mentors other survivors at Carolina's Breast Friends, an organization which provides compassion and support to people going through breast cancer.
23andMe founder and CEO Anne Wojcikci acknowledged that most cancer is not hereditary and that this test does not cover many variants tied to an even higher cancer risk.
Women with one of these variants have a 45 percent to 85 percent chance of developing breast cancer by age 70.
BRCA mutations are not the only genetic mutation that raise the risk of breast or ovarian cancer.
The three DNA mutations searched for in the screening make up a small percentage of hundreds of known BCRA mutations. Results also should not be used to guide treatment such as surgery or hormones, the FDA said.
The FDA today granted authorization for a direct-to-consumer test for a highly selected group of cancer-associated BRCA mutations. The agency also outlined special controls created to assure test's accuracy and reliability.