Talk

We are very pleased to see that Navigenics and 23andMe have reached a resolution with the State of California that allows their businesses to move forward with clarity offering their personal genome services to California residents.

It’s great news for all– for consumers, the industry, and best of all– for innovation.

It’s official: DNA Direct has received a formal letter from the California Department of Public Health (CDPH) stating that we are operating in compliance with state laboratory law. Specifically, the letter states that DNA Direct’s tests are performed only with a physician order and are conducted at licensed laboratories, and that DNA Direct gives validated interpretations of results directly to persons ordering the tests and provides publicly available education material to the person ordering the test to aid in his or her understanding.

“The CDPH has taken a proactive and decisive approach to the regulation of genetic testing with the public’s safety and concerns top of mind,” says Ryan Phelan, DNA Direct’s founder and CEO. “This communication from the CDPH enables us to reassure California residents that DNA Direct continues to operate within the appropriate regulatory framework and that consumers can depend upon us for convenient, secure and clinically-valid personal genetic information and testing services.”

(I might also add that DNA Direct was the first company to create transparent standards for web-enabled genetic services that follow medical guidelines from the National Society of Genetic Counselors and the American College of Medical Genetics for applicable tests.)

• See the letter confirming compliance from the CDPH
• See NSGC and ACMG Guidelines and Our Standards

Yet again, I’m frustrated by people confusing web access to genetic services with “direct-to-consumer” testing. Today in Science, Katsanis et al. lump DNA Direct’s gold standard services with what journalists at Newsweek are calling “snake oil.”

Contrary to the article published in Science that is being quoted in other news sources, DNA Direct is a healthcare provider just like any bricks-and-mortar genetics center. We provide medical genetic services according to evidence-based guidelines, under the oversight of a Medical Director who is an M.D. geneticist, and with a focus on proper interpretation of test results.

As a clinical provider committed to helping consumers understand genetic test results in context, it is inaccurate to describe our company as “bypassing doctors, who could help consumers interpret and use the findings.” In fact, we routinely work with physician practices to help both the referring physician and their patient access genetic testing and appropriately interpret the results.

You can read DNA Direct’s official reply to Science here, along with more info on our standards and how we meet professional guidelines.

It is my hope that this article by Katsanis et al. will fuel a debate, regardless of misinformation, prejudice or fear-mongering, that will help this industry rapidly mature. Debate can speed action and provide innovative solutions. As an insider commented, “We NEED articles like this—even if the perspective is one we do not share—because the market needs the acceleration and heat of debate.”

For more statistics about genetic testing for drug metabolism, which was the target of this article in Science, see Eye on DNA’s post and the Personalized Medicine Blog’s response.

Update 4/7: The Genetic Genealogist has a good round-up of news coverage and blog posts on this article.  He says, “…my biggest complaint with many of these articles (especially in the popular media) is that they tend to lump together every test that examines DNA. There are different types of genetic testing with different levels of quality control, interpretation, etc. The results, scientific background, and effects of tests offered by large-scale genome scanning companies, clinical entities, direct-to-consumer companies, and pharmacogenetic companies are not the same. When dealing with a readership that does not have a background in genetics (which is probably 99% of the readership), the media should take extra care to note these differences.”

Amy Harmon looks at the issue of privacy, fear of discrimination, and the very real repercussions some people are facing as a result of the tension between important medical information and lack of comprehensive legislation to protect patients’ genetic privacy.

She quotes Francis Collins, director of the National Human Genome Research Institute at the NIH, “It’s pretty clear that the public is afraid of taking advantage of genetic testing. If that continues, the future of medicine that we would all like to see happen stands the chance of being dead on arrival.”

I don’t think it’s as dire as that, but all of us — patients, physicians, industry and thought leaders — need to push for systemic solutions. Genetic testing is redefining the practice of medicine, and our convoluted infrastructure of delivering healthcare needs to adjust to accommodate it.

Harmon’s profiles of people who have chosen to test, not to test, and to test anonymously by paying for testing themselves illustrate how this tension has a fundamental impact on peoples’ health and families’ lives: (more…)