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Cease-and-desist letter sent to California-based personalized genetics startups
California likes to think of itself as a high-tech friendly place, and generally it is. However, Alexis Madrigal reports that the state government has decided to go after personal genetics companies:
Last Monday, the state's laboratory field services group issued 13 cease-and-desist letters to genetic testing companies. Wired.com obtained a copy of the letters (pdf.) from two recipients. And the tough talk in a recent teleconference among regulatory officials confirms the seriousness of the department's intent.
"We [are] no longer tolerating direct-to-consumer genetic testing in California," Karen Nickles, Chief of Laboratory Field Services at the health department, told members of the Clinical Laboratories Advisory Committee on June 13.
Targeted companies include personal genomics startups 23andMe and Navigenics. These services are seen as the leading edge of a new type of health care in which consumers can use their genetic profile to tailor their medical and lifestyle choices. The established medical community, however, is wary of the technology arguing that the medical utility of some tests is unproven. Doctors also complain that direct-to-consumer services bypass them as the gatekeepers and analysts of medical information, which they worry could confuse consumers, not to mention cost them a billing event.
The health department's actions are a direct challenge to the viability of the infant DNA-testing industry, for which physician involvement is shaping up to be a major battleground. As far back as a September 2006 meeting, health department officials were voicing concerns over "nutrigenetic tests that analyze a limited number of genes to give personalized nutritional and lifestyle recommendations."
(via Virginia Postrel's Dynamist Blog)