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

Ebony Scott
March 8, 2018

Around one in 400 people have BRCA mutations that can cause cancer, and is more common among those with eastern European or Jewish descent.

The three variants in the BRCA1 and BRCA2 genes are associated with a significantly higher risk of breast and ovarian cancer in women, and breast cancer in men. Any person who comes back with a negative for these three gene mutations, for example, could still carry other mutations in the BRCA genes that elevate their cancer risk.

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.

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The FDA stresses that despite approving this first-of-its-kind test, the fact is that it only detects three out of 1,000 DNA abnormalities which can lead to cancer, so it shouldn't replace regular mammogram tests or trips to the doctor. The FDA also cautioned against using the results to make treatment decisions, such as anti-hormone therapies or the surgical removal of the breast or ovaries. The test should not be used as a substitute for regular cancer screenings, he said. 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.

These variants are most prevalent in those of Ashkenazi Jewish descent and have been observed at much lower rates in other ethnicities. For all of these reasons, it is important for patients to consult their health care professional who can help them understand how these factors impact their individual cancer risk and what they can do to modify that risk. They provide information on what the results might mean and where to get additional information. 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.

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