FDA Gives 23andMe Approval To Check For BRCA Mutations

23andMe

23andMe

The test itself is simple enough. The variants may also be associated with an increased risk for certain other cancers.

Critics say this groundbreaking test likely will spark huge debate, saying anything regarding a serious disease needs to be left up to medical professionals.

"It is also going to add fuel to a growing fire about how we as a nation assess genetic risks for cancer, and whether society is prepared for what is inevitably going to become a genomic-influenced and informed culture of health", Lichtenfeld wrote in his blog. They provide information on what the results might mean and where to get additional information. And that can lead to cancer. As the service notes, around half of BRCA carriers who offered medical history in a study don't report cancer history among immediate relatives. But they're most common among people of Eastern European Jewish descent.

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%). "Women with one of these variants have a 45-85 percent chance of developing breast cancer by age 70".

"There are other genes besides BRCA1 and BRCA2 for breast cancer, and there are lots of other mutations on BRCA1 and BRCA2 that aren't being tested".

These three mutations, however, are not the most common BRCA1/BRCA2 mutations in the general population.

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Before you go to 23andMe's website to order a test, there are a few things you should know.

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 approved the first test that people can get without a doctor to see if they carry a genetic mutation that increases their risk for cancer.

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". Such decisions require confirmatory testing and genetic counseling.

The test, from 23nMe, analyzes DNA from saliva collected by clients, the FDA said in an agency news release. The agency also outlined special controls created to assure test's accuracy and reliability.

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