23andMe gets FDA approval for BRCA cancer risk DNA test

Mar 08, 2018, 01:48
23andMe gets FDA approval for BRCA cancer risk DNA test

The FDA has approved the first at-home genetic test for breast cancer risk.

"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.

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.

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"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". However, the test is limited in that it can only assess 3 mutations of breast cancer, most often only found in individuals of Ashkenazi (Eastern European) Jewish descent.

23andMe battled for years with the FDA over its direct-to-consumer genetic tests, and now works with the agency to do the studies that show the tests are accurate - in return for approval to market them. The use of the test carries significant risks if individuals use the test results without consulting a physician or genetic counselor.

The three mutations detected by the test occur in about 2 percent of Ashkenazi Jewish women, but only 0 to 0.1 percent of other ethnic groups, according to the U.S. National Cancer Institute.

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BRCA1/BRCA2 test has been authorized by the Food and Drug Administration (FDA).

The three DNA mutations searched for in the screening make up a small percentage of hundreds of known BCRA mutations.

"For all these reasons, it is important for patients to consult their healthcare professional, who can help them understand how these factors impact their individual cancer risk and what they can do to modify that risk", the statement continued. Test results come in the form of a report sent to the user.

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Topol's warning reflects an FDA letter sent to the service back in 2013, urging 23andMe to discontinue marketing its Saliva Collection Kit and Personal Genome Service.

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