23andMe gets FDA approval for BRCA cancer risk DNA test

23andMe can now sell a genetic test for breast cancer to anyone who wants one

USA regulators have approved the first direct-to-consumer breast cancer gene test. Now they can add information about three BRCA mutations to the health reports they issue. As geneticist Eric Topol notes on The Verge, the three variants tested here only make up a small percentage of hundreds of known mutations. And FDA warned that the tests, which work by analyzing saliva samples, carry significant risks for individuals if they are used without consulting a doctor or genetic counselor. All individuals, whether they are of Ashkenazi Jewish descent or not, may have other mutations in BRCA1 or BRCA2 genes, or other cancer-related gene mutations that are not detected by this test. Those decisions should be based on confirmatory tests and genetic counselling.

"Anyone who has a strong personal or family history of breast or ovarian cancer and is interested in finding out more about their individualized risk should consult with a genetic counselor to discuss their genetic testing options, or to discuss their results", said Erica Ramos, the group's president.

The three hereditary mutations detected by the test occur in about 2% of Ashkenazi Jewish women but are far more rare in the general population (0-0.1%). For this reason, a negative test result could still mean that a person has an increased risk of cancer due to gene mutations. The agency also noted that most cancers do not arise from genetic mutations but more likely from a combination of factors, including lifestyle and environmental factors.




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".

In addition to self-breast exams, which men and women are encouraged to do at home, there's also an at-home test approved by the Food and Drug Administration that consumers can buy.

The market authorization for the test has been granted to the consumer genome and ancestry company, 23andMe. These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for this test.

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