Who owns your DNA?

The costs of direct-to-consumer gene tests have been falling, and for under $1000 and a cheek swab or saliva sample, you can learn about a specific trait or disease risk, or get a profile of your whole genome and what it might mean according to current science. But making these tests more readily available to consumers hit some roadblocks in the last few months, when Pathways Genomics delayed plans to market the tests in Walgreens after receiving a letter from the FDA, and the University of California at Berkeley also withdrew its plan to offer individual gene analysis of three traits to incoming freshman.

The need for at least some regulation of how companies who supply genetic tests explain their results to customers became clear in July when a report by the federal Government Accountability Office demonstrated that analysis of the same gene sample could yield different results depending on the company that did the evaluation. Not only is much of this analysis unconfirmed (and might be overturned by next study) but scientists may disagree on which genetic markers are actually key to various real-life outcomes.

The implications of all this—plus a look at the use of genetic testing in cancer care and more—are discussed in a Hastings Center Report on personalized medicine, which includes a piece I wrote and a pod cast interview on Direct-to-Consumer Genetic Tests and the Right to Know. I argue that consumers own their own DNA and should have the choice to use it for maximum insights (or to ignore completely).

But that doesn't let the companies who sell genetic tests off the hook. They have the responsibility to clearly describe limitations of current knowledge. To what extent do scientists agree that a particular marker is predictive? And what is the absolute difference between someone who is at high and low risk for a disease? For example, having genetic markers for Alzheimer's disease might increase a person's risk 100 percent. That sounds terrifying. But in reality it might mean that instead of having a 1 in 100 risk of getting the disease, the person with the marker has a 2 in 100 risk. That may be significant on a population level, but it tells you little about whether a particular person will actually get the disease.

What do you think? Should consumers be free to have their genes tested on their own, or should a doctor's order be needed? And if a consumer goes it alone should the genetic testing company be responsible for providing a good explanation of limits and reliability of their results?

—Ronni Sandroff, Editorial Director, Health & Family