The California State Department of Health announced on Friday, June 13, 2008 that they have sent out cease & desist letters to 13 companies that offer consumer access to genetic tests, requiring that the companies not offer genetic tests via the Internet to California residents.
This is major news in the world of direct-to-consumer genetic testing. It requires a somewhat formal statement from DNA Direct. Here it is, from Ryan Phelan, CEO of DNA Direct:
DNA Direct has not received a cease & desist letter from the California State Department of Health. And DNA Direct has no reason to expect to receive any such letter. Our company fully complies with all applicable state and national regulations for genetic information services, including facilitating genetic test requests.
The California State Department of Health has outlined five criteria for direct-to-consumer genetic testing companies:
Is there a California Licensed Physician involved?
Are tests being authorized by a California Licensed Physician?
Does testing include pre- and post- test counseling?
Are tests being conducted at CLIA Certified labs?
Are the tests validated?
DNA Direct not only meets all five of these criteria, but it has set the industry standard for responsible delivery of genetic testing services. In 2005, DNA Direct was the first company to create transparent standards for web-enabled genetic services, which meet and exceed the consumer guidelines recently released by the National Society of Genetic Counselors and the American College of Medical Genetics. DNA Direct continues to set the industry standard by providing pre-test information and consultation, informed consent, and case review and test authorization by an M.D. medical geneticist. The company provides access to validated tests in CLIA-certified labs, post-test consultation and an in-depth, personalized report. Every report contains an individualized and detailed review of the test result, the relevant genetic disorder, and next steps, as well as a clinical summary for the individual’s primary healthcare provider, along with guidelines on how to share relevant results with family members.
DNA Direct remains committed to bringing responsible genetic testing and information services to the public.