The three variants in the BRCA1 and BRCA2 genes are associated with a significantly higher risk of breast and ovarian cancer in women, and breast cancer in men.
The newly authorized test identifies three of 1000-plus mutations associated with breast cancer risk.
US regulators have approved the first direct-to-consumer breast cancer gene test.
The National Society of Genetic Counselors recommended that people should not take the test without first consulting cancer experts, saying, "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".
The test should also not be used by consumers or health care providers to decide on any treatments, including anti-hormone therapies and preventive removal of breasts or ovaries. The test should not be used as a substitute for regular cancer screenings, he said. Most BRCA mutations that increase an individual's risk are not detected by this test. However, even prescription-ordered genetic testing is not 100% conclusive that a person will develop cancer or not.
According to a company statement, 1 in 40 people of Ashkenazi Jewish descent will carry one of these mutations, which for a woman confers a 45 percent to 85 percent chance of breast cancer arising by the time she reaches age 70.
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.
The FDA reviewed data for the test through the de novo premarket review pathway, a regulatory pathway for novel, low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device. The test report provides information describing what the results might mean, how to interpret results and where additional information about the results may be found. The agency also outlined special controls created to assure test's accuracy and reliability.