The Food and Drug Administration (FDA) sent another round of letters to companies offering genetic tests, suggesting they didn’t have the “proper clearance” to sell these tests to the public. Concern remains over how tests are marketed, and whether the consumers are receiving reliable information.
The age of DNA testing is in front of us, there is no doubt. There are many companies attempting to unlock the mysteries of human DNA and provide meaningful health information to consumers. Part of the appeal is to be the first—and to develop proprietary tests or data interpretations.
One of the pillars of science is reproducibility. Can the test be performed by independent laboratories, producing the same result? In the case of companies taking consumers data and filtering it by scientists to reveal health “predictions,” they are perhaps reluctant to share their methods. Therefore the results are up for interpretation.
And there-in lies one of the two main issues. One, what is the proper oversight by a federal regulation team on cutting edge DNA interpretations, and two, how can the average consumer interpret the results if they are provided direct-to-consumer, cutting out the physician or health care provider? (then there is the question of whether the physician can even interpret the results.)
In his article “If You Paid $500 for a Gene Test, Would You Know What to Do With It?”, John Tozzi writes “DNA tests can reliably establish family ties, like paternity tests, or reveal a person’s ethnic heritage. They can also tell whether people are at risk for certain rare diseases like cystic fibrosis that are directly linked to genetic mutations, or for passing the risk on to their children. But when it comes to information relevant to people’s health, especially about common conditions like heart disease or diabetes, the value of genetics becomes much murkier.”
When 23andme was asked by the FDA to halt it’s sales of their genetic tests in 2013, it was partly due to the press they and other firms were generating as research articles exposed differences in the results of testing the same DNA. Each company was testing with their own proprietary data, and producing different results for the same person. This does not mean 23andme results were wrong—in fact, 23andme recently re-appeared with FDA approval on a limited set of genetic tests this year.
The number of approved genetic tests grows every year. Based on popular opinions, the results of such tests should continue to go through and not around physicians, who are there to help interpret the results and discuss the next steps. The other popular opinion is that we are still at the infancy DNA testing, and that the age of DNA testing is still in front of us.