Genetic testing, once limited to experts, is now accessible to the general public with a few clicks. Couple this with the Internet and social media having closed the information gap that once left decision making solely to physicians, and we've undoubtedly arrived at a false sense of medical expertise among patients. These tests provide consumers with highly personalised data. While genetic counsellors are excellent resources for proper interpretation of data generated from DTC genetic testing, most patients do not receive proper counselling from a genetics professional due to cost barriers.
So how did we get here? The distinction between FDA marketing authorisation and FDA approval is highly significant. FDA approval is considered a formal endorsement that the intervention is proven to be safe and effective, while FDA marketing authorisation is granted after a favourable risk-benefit analysis but is not considered an endorsement of its use. In FDA's authorisations of genetic tests, the FDA made clear their viewpoint on the limitations of these reports, yet decided to authorise them anyway.
A careful analysis of the advantages and disadvantages of DTC clinical genetic testing paints a complicated portrait. In many cases, DTC testing can provide helpful information for patients who would have otherwise not undergone testing. However, when used incorrectly or without proper guidance, testing can lead to false positives and negatives, unnecessary familial testing, extra costs and anxiety.
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