There's a New Over-the-Counter Test for Breast Cancer Risk

10 March, 2018, 01:25 | Author: Jeffery Armstrong
  • 23andMe

The test, which analyzes DNA from saliva, can only detect three out of more than 1,000 known inherited BRCA gene mutations.

The US Food and Drug Administration has approved the first home test for consumers to check breast cancer risk. 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.

"The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk", said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health, in an FDA press release. Test results come in the form of a report sent to the user. The forthcoming kit, which will be made available without a prescription, tests for BRCA1 and BRCA2, which are linked to higher risk of ovarian, break and prostate cancer. Women who carry any of these mutations have a 45% to 85% breast cancer risk. There's a 2 percent risk of it for Askhenazi Jewish women, but less than 0.1 percent for everyone else. "I think genetic testing is best used in the context of all of your ongoing medical care". The FDA expanded that today, adding breast cancer risk testing onto the approved list.

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"One thing I want people to think about is how prepared you are for this information", she said.

23andMe battled for years with the FDA over its direct-to-consumer genetic tests, and now works with the agency to do the studies that show the tests are accurate - in return for approval to market them.

Also, she said, "You have to think about family dynamics", among relatives who share your genes.

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Your ancestry picture is about to get bigger and more clear.

In that respect, the service could potentially raise a red flag and lead customers to get an additional screen. When they carry mistakes themselves, the fix isn't made, or it's made improperly.

The variants may also be associated with an increased risk for certain other cancers.

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However, this does not find all genes that cause cancer, the FDA cautioned.

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