FDA Starts to Look at DTC Genetic Testing

by jeeg 14. June 2010 23:58
The Food and Drug Administration is cracking down on 23andMe and other companies that sell genetic tests directly to consumers. The F.D.A. sent letters this week to five companies involved in that business, saying their tests are medical devices that must receive regulatory approval befo... [More]

FDA sends letters to Illumina and genomics suspected of selling unapproved products

by jeeg 12. June 2010 00:26
  FDA has informed four consumer genomics services providers and Illumina that it believes the firms are selling unapproved diagnostic devices, according to a report published by the GenomeWeb Daily News. Letters were sent to Knome, 23andMe, Decode Genetics, and Navigenics. Illumina also ... [More]
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