23andMe gets FDA approval for BRCA cancer risk DNA test

Brittany A. Roston - Mar 6, 2018
23andMe gets FDA approval for BRCA cancer risk DNA test

The FDA has approved a 23andMe’s cancer risk test, one that provides the results directly to the consumer rather than to a doctor who would then provide their patient with info. The approval is specifically for the Personal Genome Service Genetic Health Risk (GHR) Report for the BRCA1/BRCA2 test revealing breast, prostate, and ovarian cancer risk.

Early in its history, 23andMe offered health-related information based on an analyses of the customer’s DNA. 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. That happened in 2013, but things started changing slowly in 2015.

Things changed in a big way in 2017 when the FDA authorized 23andMe to provide direct-to-consumer DNA testing for 10 conditions like celiac disease, Parkinson’s, Alzheimer’s, and more. The FDA expanded that today, adding breast cancer risk testing onto the approved list. As with the first 10 tests, the company is authorized to provide the results directly to the customer.

Still, the approval comes with a big warning: customers shouldn’t rely on the test as a substitution for traditional cancer screening, and they should still learn which lifestyle factors increase and decrease their risk. Explaining that is the FDA’s Office of In Vitro Diagnostic and Radiological Health acting director Donald St. Pierre:

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. 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.


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