After I posted about the latest step the Food and Drug Administration (FDA) is taking towards regulating home genetic tests, I happened across this rather strenuous objection to the idea from Razib Khan at Gene Expression. He’s quite concerned about being denied access to his genetic code, and I see his point.
The reason why I’m not with him on having fewer regulations over home genetic tests is that I lack confidence in companies being able to provide an accurate representation of what the results of these tests mean. And what’s just as important is whether or not these tests will effectively communicate what they don’t mean. I’m not keen on people taking actions based on incomplete understanding, particularly when they can affect health care and health insurance costs.
Access to one’s genome, however, should be maintained, and I think the Myriad Genetics case (which will be heard on appeal to the Federal Circuit in April) may be instructive here. Part of the benefits of invalidating the patent on the gene mutations associated with certain kinds of breast cancer is that folks can obtain a second opinion when their tests come back positive. Controlling the tests for certain genetic markers should not be extended to control over the associated genetic code.