First At-Home Genetic Test For Breast Cancer Risk Approved

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"These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population", the FDA said in a statement. Most BRCA mutations that increase an individual's risk are not detected by this test.

Breast cancer test kits by genetic testing company 23andMe just received Food and Drug Administration approval.

However, this does not find all genes that cause cancer, the FDA cautioned.

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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.

People shouldn't take the test without talking to an expert, the National Society of Genetic Counselors said.

The FDA stresses that despite approving this first-of-its-kind test, the fact is that it only detects three out of 1,000 DNA abnormalities which can lead to cancer, so it shouldn't replace regular mammogram tests or trips to the doctor. Such decisions require thorough testing and genetic counseling, the FDA added. Most breast cancer mutations that increase a person's risk are not detected by this test. 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.

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The three variants of the gene are found most often in people of Ashkenazi Jewish descent, with one in 40 people of that background carrying one.

Women with one of these variants have a 45 percent to 85 percent chance of developing breast cancer by age 70.

The three DNA mutations searched for in the screening make up a small percentage of hundreds of known BCRA mutations.

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The FDA stressed that consumers and health care professionals should "not use the test results to determine any treatments, including anti-hormone therapies and prophylactic removal of the breasts or ovaries". Along with this authorization, the FDA is establishing criteria, called special controls, which set forth the agency's expectations in assuring the test's accuracy, reproducibility, clinical performance and labeling. They provide information on what the results might mean and where to get additional information.