FDA Warns Gene Test Makers They Need Agency OK

Law360, New York (June 14, 2010, 2:37 PM EDT) -- The U.S. Food and Drug Administration has sent letters to five personal genomics companies warning them that their genetic home test kit products are being sold without the appropriate regulatory approval.

The agency sent letters Thursday to Navigenics Inc., 23andMeInc., deCode Genetics Inc., Illumina Inc. and Knome Inc. saying the companies' products qualify as medical devices under the relevant statutes that require FDA approval before they can be sold to the public.

None of the companies have ever submitted information on the “analytical or clinical validity”...
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