23andMe Granted FDA-Approval for Genetic Test on Cancer Risk

23andMe Granted FDA-Approval for Genetic Test on Cancer Risk

Ronald Pratt
March 10, 2018

The test detects only three out of more than 1,000 known BRCA mutations.

The Food and Drug Administration approved the first at-home test that consumers can buy directly to check their breast cancer risk on Tuesday.

23andMe, a company which uses a saliva sample to analyze DNA, provides information to consumers about ancestry as well as certain genetic health risks.

USA regulators have approved the first direct-to-consumer breast cancer gene test. An oncologist at Florida Hospital says these mutations are uncommon in the general population, which means that even if it comes back negative, it doesn't mean a person won't develop the disease. But, of course, the results of the test should in no way be taken as a replacement for a visit to the doctor.

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. Women who carry any of these mutations have a 45% to 85% breast cancer risk. For the first time, the agency authorized 23andMe's test for 3 BRCA1/BRCA2 breast cancer mutations, which are most common among Ashkenazi Jews.

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"You need to be tested for the right thing", and that will not necessarily be the mutations on the new test or future home tests, she said. "You test positive for this, and all of the sudden you have this set of heavy decisions on your lap". Additionally, the FDA says that this test should not substitute for a doctor visit because it doesn't account for every possible outcome.

23andMe leaders say this is a major milestone that allows consumers to get this information without a prescription. When they carry mistakes themselves, the fix isn't made, or it's made improperly.

Green has conducted studies that suggest consumers can understand such testing and make appropriate use of the results. "We believe it's important for consumers to have direct and affordable access to this potentially life-saving information".

The test goes for $199 and will be available on the 23andMe website in a couple of weeks.

It is estimated as well that only 5 to 10 percent of cancer is caused by gene mutations inherited from a parent.