The test looks for three mutations. "While the detection of a BRCA mutation on this test does indicate an increased risk, only a small percentage of Americans carry one of these three mutations and most BRCA mutations that increase an individual's risk are not detected by this test".
However, this does not find all genes that cause cancer, the FDA cautioned.
According to a company statement, 1 in 40 people of Ashkenazi Jewish descent will carry one of these mutations, which for a woman confers a 45 percent to 85 percent chance of breast cancer arising by the time she reaches age 70. 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.
The vast majority of people with these genetic mutations have ancestral ties to the Ashkenazi Jewish population formerly living in central Europe and Russian Federation. That service ended after the FDA got involved, however, with the administration citing concerns about providing that sorts of info to individuals who may not have any medical training. "Having a negative result for this test does not mean you don't have to worry about anything else", said Elrefai.
"Most BRCA mutations that increase an individual's risk are not detected by this test", St. Pierre said. The regulator said it reviewed data for the company's test under a pathway for low-to-moderate risk devices that are not equivalent to an already marketed device. As part of the process, the FDA examined user comprehension data, using representative GHR test reports showing instructions and reports were generally easy to follow for the 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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