Direct-to-Consumer Testing for Routine Purposes.

Abstract

Direct-to-consumer (DTC) laboratory testing for routine clinical conditions, such as chronic disease monitoring and sexually transmitted infection (STI) screening, is a rapidly growing market sector. While many of the ethical and logistical issues surrounding genomic DTC testing have previously been discussed in the medical literature, there has been less focus on how routine care DTC testing presents its own opportunities to impact healthcare as well as unique challenges that must be addressed. The quality and regulatory landscape of DTC testing is complex. DTC testing laboratories are not all equal, nor are all types of medical testing appropriate for DTC marketing. Within the United States, nonmedical wellness and other DTC tests may not be reviewed by the Food and Drug Administration, and consumers may not understand the distinctions between medical and nonmedical tests. Laboratories providing medical-grade DTC testing are subject to CLIA regulations, but some DTC laboratories may not be transparent about CLIA compliance. State-level regulations as to whether DTC testing is permitted and the degree of oversight for laboratories vary as well, adding to the complexity presented to the DTC consumer.