Background: Online advertising and access to Direct-To-Consumer (DTC) medical products is a growing industry. Patients can access everything from screening and diagnostic tests to pharmaceuticals without the prescription of a physician. A major risk with this industry is that ill-informed consumers often use screening tests to test symptomatic disease. To compound the risk, many of the screening tests marketed to consumers are not evidence-based and may generate a high degree of false positive and false negative testing. Consequently, patients believing tests to be dispositive regarding results, are at high risk for self diagnosis error.
Methods: Our study is an online review of companies offering DTC screening testing, claims made regarding testing, tests available, availability of professional counseling/follow-up, and the evidence supporting test use. The evidence base for each test was evaluated using guidelines published by United States Preventive Services Task Force (USPSTF) or relevant specialty society guidelines with USPSTF guidelines were not available.
Results: Of 20 identified DTC testing companies, 95% (19/20) do not or are unclear regarding offered pre-test counseling, post-test counseling, and/or test follow-up. 127 different DTC screening tests were identified; 50% (N=63) had published guidance.19/127 (15%) of tests were Supported for ≥1 population; however, 15/19 (79%) of these tests also had Against or Insufficient Evidence recommendations. 38/127 (30%) of tests had Against recommendations for ≥1 population; most tests in this group (29/38, 69%) were advised Against in all patients or all low-risk patients. Finally, 29/127 tests (23%) had only Insufficient Evidence and 64/127 (50%) had No Guidance. Overall, only 4/127 (3%) tests were uniformly Supported for screening use.
Conclusion: Virtually all identified online-advertised DTC screening tests lack sufficient evidence-base for use. Limited oversight may lead to unnecessary and dangerous self-diagnosis and treatment that may endanger patient safety. Regulating this type of testing may help reduce diagnostic error and threats to patient-safety.
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