The Limitations of New At-Home BRCA Mutation Tests

Published on Monday, March 12, 2018 by Staff

The Limitations of New At-Home BRCA Mutation Tests

Consumers: Be Aware of the Limitations of the Newly FDA Approved At-Home Genetic Test for Three of More than 1,000 known BRCA mutations

(The following is based on the FDA’s March 6, 2018 News Release)***

On March 6, 2018, the US Food and Drug Administration announced its approval of a home-test to report whether or not a consumer carries three (3) cancer gene mutations that are most common among people who are of Ashkenazi (Eastern European) Jewish descent. Test results are only for three specific BRCA1/BRCA2 breast cancer gene mutations out of more than 1,000 known BRCA gene mutations.

Caution: Though most common in people of Ashkenazi Jewish descent, these three mutations are NOT the most common BRCA1/BRCA2 mutations in the general population.

Caution: The test does NOT provide information about or measure a person’s overall risk of developing any type of cancer.

The FDA granted 23andMe® the rights to market the at-home test to consumers who will use a self-collected saliva sample for the test. DNA in the saliva is then analyzed to detect whether or not the consumer may be at an increased cancer risk. If the result is positive for a woman, she may be at an increased risk of developing breast and ovarian cancer. If positive for a man, he may be at an increased risk of developing prostate cancer.

Caution: A negative result from this test does NOT rule out the possibility that an individual carries other BRCA mutations that increase cancer risk.

Caution: The test does NOT provide information about or measure a person’s overall risk of developing any type of cancer.

In the March 6th News Release, the acting director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, Donald St. Pierre, advises: “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. 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.”

Caution: The use of this test carries significant risks if individuals use the test results without consulting a physician or genetic counselor.

Citing a study by the National Cancer Institute, the FDA reports that “the three BRCA1/BRCA2 hereditary mutations detected by the test are present in about 2 percent of Ashkenazi Jewish women…but rarely occur (0 percent to 0.1 percent) in other ethnic populations. All individuals, whether they are of Ashkenazi Jewish descent or not, may have other mutations in BRCA1 or BRCA 2 genes, or other cancer-related gene mutations that are not detected by this test.”

Caution: While this test is approved for home use and will soon be the subject of direct-to-consumer advertising, consumers should exercise caution in their use of the results and always consult their physicians and other health care providers about what the results mean and how to mitigate cancer risk.


(*** This post provides information intended to help consumers make informed decisions and choices about their health. Such information is not intended to, and does not, constitute medical advice. Consumers should always consult their physicians and other health care providers for medical advice. This post borrows heavily from the FDA’s March 6, 2018 News Release which can be found at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599560.htm.)

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