U.S. FDA Allows 23andMe to Sell Test for 3 Mutations of Breast Cancer Gene

March 6, 2018

(Reuters) – The U.S. Food and Drug Administration on Tuesday allowed genetic testing company 23andMe to market directly to consumers its test that will help assess three mutations in a common type of breast cancer gene.  The drug regulator said the test, which work by analyzing DNA collected from saliva samples, provides genetic risk information but cannot determine a person’s overall risk of developing a disease or condition.

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