Those DNA test kits that you can buy from a website sure look tempting. Genealogists often find them interesting because they can learn more about their ancestors based on the analysis of their DNA sample. Many people use these tests to learn more about their health risks. The Food and Drug Administration is considering putting regulations in place regarding these direct to consumer DNA kits. You may want to wait a little longer before purchasing one.
In some cases, doctors will recommend that a patient have genetic testing done. The purpose may be to determine the risk a couple has of passing a certain genetic mutation onto their child. It could be a way to learn a patient’s risk for cancer. The doctor can review the results of these genetic tests, and recommend a course of treatment that is best for the patient. In short, this type of genetic testing is reliable, and comes with the expert attention of physicians.
On the other hand, there have been questions about the reliability of the genetic test kits that are sold by private companies such as DeCodeME, 23andME, and Navigenics. The concern is that these type of DNA testing kits could be giving people incomplete information about their health. The tests do not come with any form of genetic counseling, which can be problematic for people who got results indicating that they have an incurable disease. There is the potential that a person will decide to stop taking their medication because one of these DNA kits said that they were not at risk for the disease that their doctor was treating them for. It can be kind of scary, when you think about it.
The FDA will be asking experts if these kinds of genetic tests can be placed into different categories. The categories might be: tests that look for diseases that can be inherited, tests that predict the risk of a future disease (such as breast cancer), and tests that predict the treatment response to a specific drug. The FDA wants the panel of experts to figure out how much evidence is required to prove that the direct to consumer DNA tests actually can do what they claim they can.
In the past, the FDA has approved certain kinds of home testing kits, such as those used to test glucose, cholesterol, and pregnancy. It is possible that a new category of testing kits may need to be created for the home DNA kits. The FDA is not going to review the genetic testing that doctors order for patients, the kind that are used to uncover family history, or the ones used by law enforcement. So, go ahead and use these DNA kits to learn more about your ancestors. Just don’t use them to create your medical family tree right now.
Image by David Orban on Flickr