DTC and Regulating Medical Advice

by jeeg 30. July 2010 19:11
  Last week’s Congressional hearings on the direct-to-consumer genetics industry (featuring a provocative GAO report based on covertly recorded phone calls made to major DTC companies) have spurred plenty of discussion, including Daniel MacArthur’s post at Genomes Unzip... [More]

House Committee Questions DTC Companies

by jeeg 23. July 2010 14:39
The House Energy and Commerce Subcommittee on Oversight and Investigations grilled representatives from 23andMe, Navigenics, and Pathway Genomics over the GAO investigation and other findings during a Wednesday hearing held to discuss the public health effects of direct-to-consumer genetic tes... [More]

Undercover Investigation Hits DTC Testing Companies Hard

by jeeg 22. July 2010 23:21
An undercover investigation of some firms that sell genetic test kits to consumers found misleading test results and “egregious examples of deceptive marketing,” according to a report published today by the Government Accountability Office.     Federal investigators... [More]

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]

Congress Investigates DTC Genomics

by jeeg 26. May 2010 02:01
A Congressional committee opened an investigation of three direct-to-consumer genetic testing companies this week. The House’s Committee on Energy and Commerce sent requests to the CEOs of 23andme, Navigenics and Pathway Genomics for a wide array of information about the companies&rsq... [More]
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