Abstract

Direct-to-consumer advertising of genetic tests is prevalent, poorly regulated and fraught with potential negative public-health ramifications. While some genetic tests are available through means that safeguard patient understanding of the implications of having genetic tests performed, others are available to anyone who has a credit card, without any individualized counseling, assessment of whether such tests are indicated, or interpretation of test results. While the US FDA, the Centers for Medicare and Medicaid Services and the Federal Trade Commission all have a regulatory role, most experts agree that the industry is not adequately being reigned in to best protect the public it serves.