How FDA and 23andMe, Inc. Dance Around Evidence That Is Not There

On July 20, 2010, Andrew Alexander, founder and director of easyDNA, received a letter from the US Food and Drug Administration. The FDA had noticed that easyDNA was marketing the "Genetic Predisposition Health Test, a home-use device that is intended to allow individuals to discover whether they are genetically predisposed towards developing a number of diseases and medical conditions, including cardiovascular conditions, different types of cancers, disorders of the immune system, diabetes as well as medical conditions related to ageing," a test that the FDA had not approved.

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