FDA Gives 23andMe Approval To Check For BRCA Mutations

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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.

It's called 23andMe, and tests for three of the more than 1,000 genetic mutations linked to breast cancer. "The variants may also be associated with an increased risk for certain other cancers". The test should not be used as a substitute for regular cancer screenings, he said.

Breast cancer is the second-biggest cancer killer of American women, after lung cancer.

The agency stressed that this test should not be used as a replacement for a visit to the doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk.

BRCA1 and BRCA2 are DNA fix genes. As the service notes, around half of BRCA carriers who offered medical history in a study don't report cancer history among immediate relatives. It can not determine a person's overall risk of developing cancer.

These variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities.

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An estimated 55 to 65 percent of women with a cancer-causing BRCA1 mutation will develop breast cancer by age 70, the National Cancer Institute says.

BRCA mutations are not the only genetic mutation that raise the risk of breast or ovarian cancer. For this reason, a negative test result could still mean that a person has an increased risk of cancer due to gene mutations.

The newly approved 23andMe test will not find all of these mutations.

The prescription-free test is the first to report on three specific BRCA1 and BRCA2 breast cancer gene mutations, according to the FDA.

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".

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.


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