23andMe gets FDA approval for BRCA cancer risk DNA test


The U.S. Food and Drug Administration (FDA) authorized the Personal Genome Service Genetic Health Risk Report, by 23andMe Inc., on Tuesday, which will report on three specific BRCA1/BRCA2 breast cancer gene mutations.

The National Society of Genetic Counselors recommended that people should not take the test without first consulting cancer experts, saying, "Consumers who test positive for these mutations need to be retested in a clinical setting under the supervision of a medical professional before moving forward with any medical decisions".

Donald St. Pierre of the FDA's Office of In Vitro Diagnostics and Radiological Health said in a statement announcing the approval that the test is intended for people who might not otherwise get genetic testing, adding that "it has a lot of caveats".

"Being the first and only direct-to-consumer genetics company to receive FDA authorization to test for cancer risk without a prescription is a major milestone for 23andMe and for the consumer", said Anne Wojcicki, 23andMe CEO and co-founder, in a press release.

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If it comes back positive for any of the three genetic mutations, like BRCA, the patient is instructed to see a doctor. "The test only detects three out of more than 1,000 known BRCA mutations".

After DNA analysis from a self-collected saliva sample, the results then detail whether a woman is at an increased risk of developing breast and ovarian cancer and whether a man is at an increased risk of developing breast or prostate cancer. The test also does not provide information on a person's overall risk of developing any type of cancer. 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.

The FDA today granted authorization for a direct-to-consumer test for a highly selected group of cancer-associated BRCA mutations. The agency also noted that a majority of cancers are caused by lifestyle factors, such as smoking, obesity, hormones, and other habits.

The regulator said it reviewed data for the company's test under a regulatory pathway for low-to-moderate risk devices that are not equivalent to an already marketed device. Test results come in the form of a report sent to the user.



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