FDA Approves Direct-to-Consumer Cancer Mutation Test

23andMe image

According to the National Cancer Institute, the three mutations are present in ~2% of Ashkenazi Jewish women compared to 0 - 0.1% in other populations.

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.

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A view shows the U.S. Food and Drug Administration headquarters in Silver Spring Thomson Reuters (Reuters) - The U.S. Food and Drug Administration on Tuesday allowed genetic testing company 23andMe to market directly to consumers its test that will help assess three mutations in a common type of breast cancer gene. "But it has a lot of caveats", said Donald St. Pierre, acting director of the Office of In Vitro Diagnostics and Radiological Health in the FDA's Center for Devices and Radiological Health.

"I don't want to trivialize the potential for serious psychological burden that this risk information might provide; however, it is risk information that we know can lead to life saving interventions", Green said. 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. "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". For this reason, a negative test result could still mean that a person has an increased risk of cancer due to gene mutations. The agency also noted that a majority of cancers are caused by lifestyle factors, such as smoking, obesity, hormones, and other habits. The variants also are associated with ovarian cancer in women and breast and prostate cancer in men. Test results come in the form of a report sent to the user. 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. The agency also outlined special controls created to assure test's accuracy and reliability.

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The FDA granted the marketing authorization to 23andMe.

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