TalkDNA Direct in Full Compliance with California Regulations
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:
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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.
-Ryan Phelan, CEO
DNA Direct
June 17th, 2008 at 4:10 pm
I’m confused about what the doctor does in all of this. How does the M.D. know whther or not to authorize a test if I am an anonymous consumer?
June 20th, 2008 at 12:28 pm
Hi Barry, thanks for your question.
Everyone who orders with DNA Direct takes a questionnaire, which is based on medical guidelines, that collects personal and family history info. The answers help us determine who is appropriate for testing (i.e., will test results be of benefit to them?). If someone is not appropriate for testing, we tell them so. Many people, in addition to the questionnaire, also have a phone consultation with one of our board-certified genetic counselors. For certain tests (such as BRCA), phone counseling is mandatory. All of this information is collected and reviewed by our clinical staff. This info helps us build a personalized, tailored report that explains and interprets the tester’s test results — “your genes in context.”
You can view a sample Personalized Report here (click the link in the right-hand nav).
More about our process is here.
More on our genetic consultations is here.
-Lisa
July 1st, 2008 at 1:55 pm
I’d like to point readers to a recent post Dr. Starr has made at KQED’s Quest blog: Genetic Testing or Recreational Genomics? It’s a more detailed discussion of what’s going on with California’s regulators than has appeared in most of the newspaper coverage. Thanks for weighing in on this, Barry.
July 1st, 2008 at 2:58 pm
Also The Genetic Genealogist, has a wonderful and comprehensive round-up of both the news coverage and blog reactions. As always, a thoughtful analysis by Dr. Bettinger.