FDA Approves 1st Home Test for Breast Cancer Genes

23andMe
23andMe
Author

08 March, 2018

For the first time the FDA has granted permission to market a direct-to-consumer genetic test to check for BRCA mutations that are associated with breast and ovarian cancer.

Men may also use the test to determine whether they have an increased risk of developing breast or prostate cancer.

To take the test, you simply check a box and mail in your saliva, but doctors warn, it won't test everyone, saying it only searches for three DNA mutations that are found most commonly in the Ashkenazi (Eastern European) Jewish ancestry.

The FDA said that while this test provides detection of a BRCA mutation, only a small percentage of Americans carry one of the variants.

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The FDA approved the first test that people can get without a doctor to see if they carry a genetic mutation that increases their risk for cancer.

Therefore, you are not completely out of harm's way if you test negative for the 3 mutations. The test should not be used as a substitute for regular cancer screenings, he said. At MedShadow, she reports on new findings and research on the side effects of prescription drugs. Those decisions should be based on confirmatory tests and genetic counselling.

The three BRCA1/BRCA2 hereditary mutations detected by the test are present in about 2 percent of Ashkenazi Jewish women, according to a National Cancer Institute study, but rarely occur (0 percent to 0.1 percent) in other ethnic populations. 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. 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. Test results come in the form of a report sent to the user. The agency also outlined special controls created to assure test's accuracy and reliability. The test has the potential to provide a false sense of safety among consumers.

The FDA granted the marketing authorization to 23andMe.


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