The Current Landscape for Direct-to-Consumer Genetic Testing: Legal, Ethical, and Policy Issues
September 2008
in “
Annual Review of Genomics and Human Genetics
”
TLDR The document concludes that the fast-growing direct-to-consumer genetic testing market lacks sufficient regulation, posing risks to consumers due to questionable test quality and accuracy.
In 2008, the document reviewed the burgeoning direct-to-consumer (DTC) genetic testing market, highlighting the lack of regulation and the potential risks to consumers. It noted that while DTC testing could increase consumer access to health information, there were significant concerns about test quality, the accuracy of information provided, and the potential for consumer harm due to misinformation. The document underscored the limited government oversight, with most tests not reviewed for clinical validity before becoming publicly available, and the dynamic nature of the DTC market, with companies frequently entering and exiting. It emphasized the need for better regulatory frameworks to ensure the quality and reliability of DTC genetic testing, pointing out that existing laws against false advertising were not widely enforced in this context. The document concluded that despite the rapid proliferation of DTC genetic tests, policies to ensure their quality were not keeping pace, presenting a challenge in establishing a coherent oversight system that protected consumers while ensuring access to valid tests.
