March 19, 2018

23andMe DNA kit lets you test breast cancer risk from home

10 March 2018, 01:26 | Leigh Flowers

FDA OKs direct-to-consumer test for certain types of breast cancer mutations

The FDA announced it will allow the genetic testing company 23and Me to market directly its breast cancer test that will help assess 3 mutations in a common form of breast cancer gene

The test looks for three mutations.

23andMe, a company which uses a saliva sample to analyze DNA, provides information to consumers about ancestry as well as certain genetic health risks.

The first consumer test for three BRCA gene mutations associated with breast, ovarian and prostate cancer risk has been approved by the U.S. Food and Drug Administration. An oncologist at Florida Hospital says these mutations are uncommon in the general population, which means that even if it comes back negative, it doesn't mean a person won't develop the disease. Test results come in the form of a report sent to the user.

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. No doctor's prescription will be needed for the test.

The FDA says the test is not a substitute for regular medical checkups and should not be used to make any medical decisions.

"One thing I want people to think about is how prepared you are for this information", she said. Their presence in any population is a risk factor and not a cancer diagnosis, and something discussed, along with other risk factors, with health care providers and genetic counselors.

Despite the possible pitfalls, home genetic testing is likely to grow and many people will not get counseling first, experts concede. When they carry mistakes themselves, the fix isn't made, or it's made improperly.

But some people will, inevitably, be blindsided by upsetting results and have to pick up the pieces with their doctors and families, Cook-Deegan said. "We believe it's important for consumers to have direct and affordable access to this potentially life-saving information".

23andMe offered BRCA testing without FDA approval several years ago, but the FDA ordered it to stop in 2013 until it could prove that test and other health tests it offered were accurate and adequately explained to consumers.

It doesn't find all cancer-causing genes - not by a long shot, the FDA said.

23andMe founder and CEO Anne Wojcikci acknowledged that most cancer is not hereditary and that this test does not cover many variants tied to an even higher cancer risk.

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