FDA Approves 1st Home Test for Breast Cancer Genes

08 March, 2018, 01:47 | Author: Andrea Terry
  • 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

As geneticist Eric Topol notes on The Verge, the three variants tested here only make up a small percentage of hundreds of known mutations.

The test, which analyzes DNA in saliva, will be marketed to consumers by privately held 23andMe.

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.

In addition to self-breast exams, which men and women are encouraged to do at home, there's also an at-home test approved by the Food and Drug Administration that consumers can buy.

It doesn't find all cancer-causing genes - not by a long shot, the FDA said. All individuals, whether they are of Ashkenazi Jewish descent or not, may have other mutations in BRCA1 or BRCA2 genes, or other cancer-related gene mutations that are not detected by this test. The FDA cautions that a negative result from the test doesn't rule out that a person has other BRCA mutations or an increased risk of 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.

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.


BRCA mutations are not the only genetic mutation that raise the risk of breast or ovarian cancer.

Things changed in a big way in 2017 when the FDA authorized 23andMe to provide direct-to-consumer DNA testing for 10 conditions like celiac disease, Parkinson's, Alzheimer's, and more.

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.

Test For Breast Cancer Gene Will Be Available In Weeks 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.

Along with the approval, the FDA is setting up special controls to ensure the test's accuracy and performance, the agency said. The agency also outlined special controls created to assure test's accuracy and reliability.

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