Direct-To-Consumer Cardiac Screening and Suspect Risk Evaluation
- Journal of the American Medical Association
Author/s: -Lovett, Kimberly M -Liang, Bryan A
Journal: Journal of the American Medical Association
Start Page: 2567
Direct-to-consumer (DTC) genetic testing has generated much concern due to nonstandardized products, unproven utility, and potential harm from testing results.1 Recommendations indicate that genetic testing should be US Food and Drug Administration (FDA)–approved, supported by predictive value and outcomes research, and offered only through qualified health care professionals.1
However, many companies offer DTC cardiac screening tests under auspices of patient empowerment and cardiac risk evaluation. DTC cardiac screening tests have been largely ignored in these discussions. Yet because cardiac disease is a leading cause of death, DTC cardiac testing has tremendous potential reach and is equally important to critically evaluate. Although concerns regarding quality control and unproven utility of DTC genetic testing are valid, cardiac screening tests have been evaluated, and under evidence-based guidelines, these tests likely pose more risk than benefit to patients. Despite the known risks of offering this DTC service, there is no requirement of these companies for full disclosure in advertising, informed consent, pretest evaluation, or posttest counseling.