LAKE CHARLES, LA (KPLC) - Genetic testing company 23andMe has been given federal approval to sell at-home test kits to detect three breast cancer gene mutations.
In a news release, the FDA says this will be the first direct-to-consumer DNA test for these particular breast cancer gene mutations.
A 23andMe spokeswoman said the test for the three BRCA1/BRCA2 breast cancer gene mutations will be added in the coming weeks to the broader "health plus ancestry" services.There will be no increase to the existing $199 dollar testing cost. The FDA confirmed that the company provides sufficient data to show that the test is accurate, so the company was granted the marketing authorization.
Consumers and healthcare professionals should not use the test results to determine any treatments, the FDA states. In addition to that, the test does not provide information on a person's overall risk of developing any kind of cancer.
The FDA says the test can only detect three out of more than 1,000 known BRCA mutations and the negative result does not rule out increased cancer risk. The FDA also reports that the tests are most common for people of Ashkenazi (Eastern European) Jewish descent and not the general population.
To read the FDA's news release in its entirety, click HERE