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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:

1. Is there a California Licensed Physician involved?
2. Are tests being authorized by a California Licensed Physician?
3. Does testing include pre- and post- test counseling?
4. Are tests being conducted at CLIA Certified labs?
5. 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

This is a guest blog post from our VP of Clinical Affairs, Trisha Brown:

The healthcare system is evolving as individuals begin to step outside of their local, or traditional, healthcare resources to find what they’re looking for. This is well-illustrated by the medical genetic testing industry, where there is a growing trend in direct-to-consumer (DTC) marketing. In response, the regulatory environment is scrutinizing the entire industry and how each company interacts with individuals.

I recently spoke on this topic at the Dark Report-sponsored Executive War College on Laboratory and Pathology Management held in Miami (where it was slightly cooler than San Francisco for a change). The audience was made up of about 650 C-suite executives and directors of clinical labs — from the big names to small pathology labs and hospitals. A major theme at the conference was that the ability to compete in the lab testing space is not about the testing itself anymore, but rather service, service, service. Labs are concerned with everything from customer phone service to how they partner with physicians to enable them to do their jobs better by providing information and effective results reporting.

I opened the second day of the conference with a presentation on the virtual medical genetic testing landscape and how it has become a DTC trend, with multiple companies offering a range of services, often at the click of a button. The regulatory scrutiny that is growing along with the industry is important because the heightened scrutiny will extend to all of the clinical laboratories — as the Secretary’s Advisory Committee on Genetics, Health and Society put it, it is becoming “increasingly difficult to distinguish genetic testing from other complex laboratory testing.”

There is also a tendency to lump all of the companies, including DNA Direct, together into one big DTC bundle, which is inaccurate given the varying service offerings. DNA Direct, for example, is committed to assessing individuals pre-test to ensure the right people get the right test at the right time. We’re also the first and only company to create transparent standards and guidelines for web-enabled services and we follow the standard medical guidelines for applicable tests; this is appealing to individuals looking for a reliable and medically sound testing experience.

I gave the example of a young Ashkenazi Jewish couple who visited their doctor to discuss carrier screening prior to their honeymoon. Unfortunately, their insurance wouldn’t cover the tests since they weren’t currently pregnant, and the cost was going to be $4,000. The couple decided to go shopping online and came to DNA Direct, where the couple was counseled to test one person at a time to eliminate unnecessary tests and costs. The groom-to-be took the bundle of tests, at a cost of $1,200, and only tested positive for the enzyme associated with Tay-Sachs. Thus his fiancée needed one $300 test to confirm whether they were at risk for offspring with any relevant diseases. This is a nice example of how individuals are taking control of their own healthcare. The opportunity for individual labs, of course, is to better educate physicians on selective testing in order to avoid costly, extraneous tests.

This is DNA Direct’s philosophy — our genetic testing tools and services empower individuals and physicians by providing guidance fortesting and context around results. We also host a number of services for labs who are trying to enhance their pre- and post-analytical solutions for physicians, so they can improve their service and keep up with healthcare innovation.

Yes, that’s the sound of champagne corks flying at DNA Direct. We’re happy to announce our next round of funding. Our newest investor, Lemhi Ventures, is focused on growing businesses that target disruptive changes in health care, to improve quality and value for consumers.

How does DNA Direct provide solutions to disruptive change? Personalized medicine, coming to you online, over the phone, at home, in your doctor’s office, and through your labs. We’re focused on making the connections between patients, physicians and institutions — closing the loop, so to speak, or addressing the gap — so that the potential of medical genetics to affect people’s healthcare and change people’s lives is realized.

Here’s the official press release: (more…)