Direct-to-consumer tests: emerging trends are cause for concern

Advances in diagnostic technology and digital health have increased the variety and volume of direct-to-consumer tests—commercial tests initiated by consumers without clinical consultation.1 Sales of these tests have surged from $15m in 2010 to $1.15bn in 2022 in the United States alone.234 As well as the better known DTC tests for covid-19, genetics, and HIV, many other types of tests are now available, including for prostate health checks, thyroid function, and food sensitivity.5678 However, no dedicated regulatory framework exists to govern the appropriate use of emerging DTC products.

Although DTC tests offer consumers more choice, accessibility, and privacy,1910 qualitative studies show that users have found decisions on selecting and purchasing tests a challenge.10 Concerningly, companies use persuasive marketing techniques such as narratives of “women’s empowerment” to promote non-evidence based health interventions.5811 As DTC tests are promoted to broad populations rather than specific groups for which there is evidence of improved health outcomes, consumers are at risk of buying products that do more harm than good. Therefore, availability of DTC tests can trigger unnecessary and inappropriate use.51213 Indeed, a qualitative study suggests that some users of DTC tests were motivated to repeat testing to seek regular reassurance, whereas others who received abnormal results did not follow-up with a general practitioner.14 Better information and regulation are essential to protect consumers from potential harms.