23andMe Granted FDA-Approval for Genetic Test on Cancer Risk

The Food and Drug Administration approved the first at-home test that consumers can buy directly to check their breast cancer risk on Tuesday.

The authorisation allows 23andMe to provide customers with information on three genetic variants known to be associated with a risk for breast, ovarian, and prostate cancer. No doctor's prescription will be needed for the test.

This approval is expected to raise concerns over whether or not people should ask for professional medical help, as this information may not be appropriately handled by everyone, cancer experts said.

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USA regulators have approved the first direct-to-consumer breast cancer gene test.

"It's better to find out sooner than later", said Charmaine Tyson, a two-time breast cancer survivor. "The variants may also be associated with an increased risk for certain other cancers". 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. The variants are found most commonly in people of Ashkenazi Jewish descent - they are "not the most common BRCA1/BRCA2 mutations in the general population", the FDA said in a statement. The test should not be used as a substitute for regular cancer screenings, he said.

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. For this reason, a negative test result could still mean that a person has an increased risk of cancer due to gene mutations. The FDA also cautioned against using the results to make treatment decisions, such as anti-hormone therapies or the surgical removal of the breast or ovaries.

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The approval comes four years after the FDA threw the brakes on 23andMe's race across the consumer genetic testing landscape in a November 2013 warning letter that amounted to a cease-and-desist order.

"These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for this test".

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  • Jermaine Castillo