The DIY test, manufactured by genetics company 23andMe, looks for three DNA mutations that are most often found in Jewish people, NBC News reports. Most BRCA mutations that increase an individual's risk are not detected by this test.
Report for BRCA1/2 (selected variants), which evaluates an individual's risk of developing multiple cancer types, according to a press release. Currently, pretty much all BRCA1 and BRCA2 screenings are called for by a doctor, for patients already identified as either having cancer, or as having a high risk of cancer. "The test should not be used as a substitute for seeing your doctor for cancer screenings or counseling on genetic and lifestyle factors that can increase or decrease cancer risk". In men, the mutations also raise the risk of breast cancer, and possibly prostate cancer as well, although the research is less clear for the latter.
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The direct-to-consumer genetic testing company 23andMe has received federal approval to inform people of breast cancer risk linked to three gene mutations, making it the first company allowed to test for cancer risk without a prescription in the United States. "But it has a lot of caveats", Donald St. Pierre, of the FDA Center for Deices and Radiological Health, said in a statement. 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. 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. "Having a negative result for this test does not mean you don't have to worry about anything else", said Elrefai. The manufacturer also submitted data on user comprehension, which showed instructions and reports were easily understood. As with the first 10 tests, the company is authorized to provide the results directly to the customer.
The Food and Drug Administration decision is a step forward for the evolving world of consumer genomics.