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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.
The FDA wanted to protect the public from tests that had no scientific basis, and which were unlikely to accurately predict disease risk. And it had a good point: most common diseases are caused by such a complex interaction between numerous genetic and lifestyle risk factors that tests based on a few genes cannot meaningfully predict diseases.
EasyDNA was among the 17 companies that received a letter from the FDA during that summer. The FDA argued that their personal genome services are medical devices that require review and approval before...
The FDA wanted to protect the public from tests that had no scientific basis, and which were unlikely to accurately predict disease risk. And it had a good point: most common diseases are caused by such a complex interaction between numerous genetic and lifestyle risk factors that tests based on a few genes cannot meaningfully predict diseases.
EasyDNA was among the 17 companies that received a letter from the FDA during that summer. The FDA argued that their personal genome services are medical devices that require review and approval before...