FDA gives nod to 23andMe for no-prescription breast cancer gene testing

23andMe

Approval of this testing a big step forward in the availability of genetic tests for consumers, but there are more than 1,000 BRCA mutations and this test does not screen for the ones that are most commonly associated with a higher risk of cancer in Americans.

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. Most cancers are not caused by genetic mutations, and the ones tracked by the test aren't the most common BRCA mutations. "The variants may also be associated with an increased risk for certain other cancers".

Report for BRCA1/2 (selected variants), which evaluates an individual's risk of developing multiple cancer types, according to a press release. Such decisions require confirmatory testing and genetic counseling.

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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. The agency also noted that most cancers do not arise from genetic mutations but more likely from a combination of factors, including lifestyle and environmental factors.

"Most BRCA mutations that increase an individual's risk are not detected by this test", St. Pierre said. The company submitted data on user comprehension studies, using representative GHR test reports, that showed instructions and reports were generally easy to follow and understood by a consumer. Additionally, the FDA says that this test should not substitute for a doctor visit because it doesn't account for every possible outcome. 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. The evaluation, through the FDA's pathway for novel, moderate-risk medical devices, required greater than 99 percent accuracy and repeatability for the assay to be approved. These special controls, when met along with general controls, provide reasonable assurance of safety and effectiveness for this test.

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