PrintThe Burrill Report (June 21, 2010): FDA Moves Toward Regulating Direct-to-Consumer Genetic Tests (.MP3,13.59 Mb)
The U.S. Food and Drug Administration is taking steps to regulate direct-to-consumer genetics tests. The agency recently sent letter to 23andMe, Navigenics, deCODE Genetics, Knome, and Illumina stating that they are marketing medical devices without the necessary review and approval from the agency. The action follows last month’s controversy over Pathway Genomics aborted attempts to sell its test kits through the retail drugstore chain Walgreens. We spoke to Daniel Vorhaus, an attorney with Robinson, Bradshaw & Hinson and Editor of the Genomics Law Report, about the FDA letters, how these companies are responding to the agency, and what it all means to the future of the genetic testing industry.
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