Recently, the FDA put together an advisory panel in order to figure out what regulations should be put in place in regards to direct to consumer DNA testing kits. The opinions of the experts has lead the FDA to conclude that at least some of these genetic tests should require the involvement of a doctor. If so, this could, potentially, change how easy it is for genealogists to use these tests to create their medical family tree.
The discovery of the human genome, and all the research that has been done on it, has occurred in a relatively short span of time. Scientists are quickly discovering the genetic combination, or the genetic mutations, that indicate the risk a person has of developing a specific disease or disorder. It is these kinds of discoveries that have enabled the multitude of companies that sell direct to consumer genetic testing kits to be able to offer them, and to be able to interpret data that comes from the DNA sample that a consumer provides.
Right now, genealogists, (and everyone else), can purchase a DNA testing kit from companies like DeCodeME, 23andME, Navigenics, and more, and have it sent out directly to them. The company will analyze the person’s DNA, in a relatively short span of time, and will make those results available to the consumer. This can be done by having the consumer make an account on the website of the company, which can only be accessed by a password. Some of them may send the results back to the consumer through the mail.
Just like that, a person could be on his or her way to discovering ancestors that were previously unknown. A person could learn more about the parts of the world their ancestors must have come from, based on clues in the person’s own DNA.
Or, a person could learn that he or she is at risk for developing certain kinds of cancer, Alzheimer’s disease, or cystic fibrosis. This could be alarming, especially if there are questions about the reliability of the DNA testing kit itself. This is part of the reason why the FDA began asking experts about how genetic testing kits should be regulated. Right now, it appears that the FDA is leaning towards a requirement that certain kinds of genetic testing kits be sold to doctors instead of directly to consumers. Specifically, the FDA is targeting the kinds of genetic tests that predict health risks, or that make medical claims, (and not the ones that are used only for the purposes of ancestry). This decision is based on comments made by experts after two days of hearings regarding the tests.
This could mean that, in the near future, if you want your DNA tested because you want to know your risk of developing a certain disease, you will need to have your doctor order the test for you. Your doctor could guide you through what you should, or shouldn’t, do, based on the results of the test. One can only imagine the implication this potential requirement by the FDA will have in regards to health insurance.
Image by David DeHoey on Flickr