FDA approves at-home breast cancer gene test

08 March, 2018, 03:47 | Author: Kristen Mcgee
  • 23andMe kit

Still, the approval comes with a big warning: customers shouldn't rely on the test as a substitution for traditional cancer screening, and they should still learn which lifestyle factors increase and decrease their risk.

The approval will likely set off a debate over whether people can handle this type of genetic information without professional help, cancer experts said.

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.

If you could take a test and have it determine whether you are at an elevated risk for developing breast cancer, who wouldn't want to know such valuable information?

In a reversal of fortune for 23andMe, the US Food and Drug Administration (FDA) has granted the company the first-ever authorization for direct-to-consumer genetic testing for cancer risk without a prescription. On the other hand, those who find they do have the mutations may needlessly worry - having the mutation does not guarantee you will get cancer.

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The test, which analyzes DNA from saliva, can only detect three out of more than 1,000 known inherited BRCA gene mutations. The test report provides information describing what the results might mean, how to interpret results and where additional information about the results may be found. As the service notes, around half of BRCA carriers who offered medical history in a study don't report cancer history among immediate relatives.

The three variants in the BRCA1 and BRCA2 genes are associated with a significantly higher risk of breast and ovarian cancer in women, and breast cancer in men.

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.

And the FDA said no doctor or patient should use the test as a basis for deciding treatment, "including anti-hormone therapies and prophylactic removal of the breasts or ovaries". Along with this authorization, the FDA is establishing criteria, called special controls, which set forth the agency's expectations in assuring the test's accuracy, reproducibility, clinical performance and labeling.



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