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23andMe DNA kit lets you test breast cancer risk from home

08 March 2018

For the first time the FDA has granted permission to market a direct-to-consumer genetic test to check for BRCA mutations that are associated with breast and ovarian cancer.

The Food and Drug Administration just approved an at-home test that allows people to check their risk of breast cancer themselves.

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

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Women with one of these variants have a 45-85% chance of developing breast cancer by age 70. They could also face elevated breast cancer risk due to other gene variations or other factors.

Report for BRCA1/2 (selected variants), which evaluates an individual's risk of developing multiple cancer types, according to a press release.

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 FDA cautions that the test only detects 3 out of more than 1000 BRCA mutations, meaning that a negative result may not necessarily indicate whether or not a patient carries another variant that increases the risk of cancer. The test should not be used as a substitute for regular cancer screenings, he said.

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23andMe earned the authorization based on data showing accurate identification of these three variants in saliva.

Still, the company, which already tests DNA for other health risks as well as ancestry, said this cancer test is "a step in the right direction".

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. The company submitted data on user comprehension studies, using representative GHR test reports, that showed instructions and reports were generally easy to follow and understood by a consumer. Anne Wojcicki, co-founder and chief executive of 23andMe, said the company's experience selling the test before 2013 in the U.S., United Kingdom and Canada had provided insight into how useful the information can be, particularly to customers who did not realize they had Ashkenazi Jewish heritage.

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23andMe DNA kit lets you test breast cancer risk from home