Breast Cancer Screening Guidelines Revised
At-Home Breast Cancer Gene Test Approved by FDA
23andMe receives approval to report risk of carrying gene that increases risk for breast, ovarian, and prostate cancer.
By George Vernadakis
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March 6, 2019
The Food and Drug Administration (FDA) today granted authorization for a direct-to-consumer genetic test for the risk for certain cancers. The authorization allows 23andMe, a personal genetics company, to report on genetic risk for breast, ovarian, and prostate cancers.
Specifically, 23andMe will report on three variants in the BRCA1 and BRCA2 genes associated with a significantly higher risk of breast and ovarian cancer in women, and breast cancer in men. The variants, which may be associated with certain other cancers, are most prevalent in people of Ashkenazi Jewish descent. About 1 in 40 individuals of Ashkenazi Jewish descent has one of the three variants.
Among women with the BRCA1 mutation, the lifetime risk of breast cancer is as high as 80 percent. For women with the BRCA2 mutation, the lifetime risk of breast cancer is around 45 percent.
The applies specifically to the 23andMe BRCA1/BRCA2 (Selected Variants) Genetic Health Risk Report. The test report does not represent overall risk of developing any type of cancer.
Limitations of Testing
“This authorization is incredibly valuable for those who might not be aware of their Ashkenazi Jewish descent or aren’t familiar with their family history of cancer,” said Anne Wojcicki, 23andMe CEO and cofounder, in a statement. “But it’s important to understand that the majority of cancer is not hereditary, our test does not account for all genetic variants that can cause a higher risk of cancer, and people should continue with their recommended cancer screenings.”
“This test provides information to certain individuals who may be at increased breast, ovarian, or prostate cancer risk and who might not otherwise get genetic screening, and is a step forward in the availability of DTC genetic tests. But it has a lot of caveats,” 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 statement. “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,” he added.
Clinical guidelines for genetic risk evaluation are based primarily on a family history of certain cancers. Still, an article published in September 2014 in theJournal of the American Medical Associationargued for broader population-based screening. According to the article, only 19 percent of U.S. primary care physicians accurately assessed family history for BRCA1 and BRCA2 testing.
Video: Tomosynthesis: New Breast Cancer Screening - Mayo Clinic
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