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08 March 2018, 01:38 | Franklin Nunez
Just put your saliva in the mail
The test looks for three mutations.
"Being the first and only direct-to-consumer genetics company to receive FDA authorization to test for cancer risk without a prescription is a major milestone for 23andMe and for the consumer", Anne Wojcicki, CEO and cofounder, said in a press release.
The FDA's director of the Office of In Vitro and Radiological Health, Donald St. Pierre noted that the test has a lot of caveats.
23andMe previously included breast cancer risk in its genetic tests in the USA, but stopped in 2013 after the FDA sent the company a warning letter stating the company was marketing its test without approval.
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The Personal Genome Genetic Health Risk Report was first approved last April to provide information for a broad range of genetic disorders. (These three are also not the most common BRCA mutations.) The testing done in professional medical labs is more detailed, and can definitively find more of genetic risk factors. Men may also use the test to determine whether they have an increased risk of developing breast or prostate cancer. Due to the mentioned caveats, the agency indicated that patients should not exclusively rely on this test, nor should the test be used to determine a cancer treatment.
There are over 1000 known BRCA mutations so a negative test result does not rule out the possibility that an individual carries other BRCA mutations. These variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities. 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 said that while this test provides detection of a BRCA mutation, only a small percentage of Americans carry one of the variants. The agency also outlined special controls created to assure test's accuracy and reliability. 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.
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