Can False General Health Genetic Tests Hurt the Consumer? 
​​[Posted on: Thursday, November 16, 2017]

Last week FDA announced initiatives that would reduce the direct regulation of most general health genetic tests citing low risk of such tests. A new study published this week raises concerns about incorrect genetic tests of this kind citing specific clinical outcomes linked to the false results. General Health Risk (GHR) tests are designed to predict the genetic disposition of an individual to future health issues. These tests are not considered diagnostic tests by FDA since these tests are primarily intended for consumer education and not to diagnose an existing disease. Many of these tests are based on existence or absence of genetic markers. Most genetic markers used to make predictions about disposition to future diseases in currently healthy individuals are not standardized. These are based on few academic studies and heavily rely on extrapolation from algorithms, which may not have been fully validated. The reliability of these tests is hence questionable. In an observational study, participants who were told incorrectly that they have genetic markers for depression, reported feeling depressed and even retroactively thought that they had depression for longer times, even though there was no link between their genes and depression. Just by telling participants that their genes predisposed them to depression, lead them to higher levels of depressive symptomatology over the previous 2 weeks, compared to those who did not receive this feedback. In another group, participants who were falsely told that they did not have a genetic risk for obesity and that exercise is less important for them were much more likely to eat unhealthy foods than were participants who were not given this information. The study concluded that for conditions highly reliant on patient-reported outcomes, GHR tests could have harmful consequences. Most mental health conditions, pain, and quality of life measures are based on patient reported outcomes and hence could be highly affected by incorrect GHR tests. For conventional diagnostic assays, FDA approval requires extensive testing to evaluate the accuracy and reliability of the given assay. For non-FDA regulated tests, such testing is frequently forgone due to commercial interests. It would be expected that with lower regulatory burden, GHR tests with less robust testing will become available. It is imperative that marketing of such tests carry with them clear warnings and disclaimers about their potential utility to change behavior. In an ideal World, preference should be given to tests that encourage healthy behavior irrespective of the outcome of the test. The potential risk of false GHR still falls below the threshold of needing higher regulation. Such studies will likely not impact FDA’s current hands-off approach to regulating these tests.