FDA Approves 1st Home Test for Breast Cancer Genes
FDA Approves 1st Home Test for Breast Cancer Genes
FDA Authorizes Direct-to-consumer Test that Reports Three Mutations in the BRCA Breast Cancer Genes
07 March, 2018, 16:17
US regulators have approved the first direct-to-consumer breast cancer gene test. In a statement, the FDA said that the three mutations 23andMe's test evaluates are BRCA1/2 variants that occur most commonly in people of Ashkenazi Jewish descent.
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The FDA announcement stresses that the results of the tests are limited in scope, do not mean other cancer-causing gene mutations are not present, and should not be used to determine treatments without other testing and genetic counseling.
The FDA says the test is not a substitute for regular medical checkups and should not be used to make any medical decisions.
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.
Donald St. Pierre of the FDA's Office of In Vitro Diagnostics and Radiological Health said in a statement announcing the approval that the test is intended for people who might not otherwise get genetic testing, adding that "it has a lot of caveats". The American Cancer Society says this year, it will be diagnosed in 260,000 women and a few men, and will kill almost 41,000.
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The test analyzes DNA collected from a self-collected saliva sample, and the report describes if a woman is at increased risk of developing breast and ovarian cancer, and if a man is at increased risk of developing breast cancer or may be at increased risk of developing prostate cancer.
Around one in 400 people have BRCA mutations that can cause cancer, and is more common among those with eastern European or Jewish descent.
People shouldn't take the test without talking to an expert, the National Society of Genetic Counselors said.
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.
Granted to 23andMe, the authorization covers the Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2 (selected variants). To win approval, the company submitted data showing its instructions and reports are easy to understand.
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