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FDA approves 23andMe test to evaluate cancer risk
08 March 2018, 01:49 | Violet Powell
FDA Authorizes First Direct-to-Consumer BRCA Mutation Test
"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", the company's CEO Anne Wojcicki said in a release tied to the announcement.
Limited test: There are more than 1,000 known mutations found on BRCA genes, and 23andMe's test doesn't yet look at the most common ones in the general population.
In addition to self-breast exams, which men and women are encouraged to do at home, there's also an at-home test approved by the Food and Drug Administration that consumers can buy. However, the test is limited in that it can only assess 3 mutations of breast cancer, most often only found in individuals of Ashkenazi (Eastern European) Jewish descent. 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.
And the FDA said no doctor or patient should use the test as a basis for deciding treatment, "including anti-hormone therapies and prophylactic removal of the breasts or ovaries".
These variants are most prevalent in those of Ashkenazi Jewish descent, and have been observed at much lower rates in other ethnicities.
"Consumers who test positive for these mutations need to be retested in a clinical setting under the supervision of a medical professional before moving forward with any medical decisions", the National Society of Genetic Counselors (NSGC) told NBC News. Most cancers are not caused by genetic mutations, and the ones tracked by the test aren't the most common BRCA mutations. "Having a negative result for this test does not mean you don't have to worry about anything else", said Elrefai. The test has the potential to provide a false sense of safety among consumers.
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