DTC Tests

The democratization of health has meant that patients have access to their health information and are informed decision makers. Previously, doctors did not tell patients when they had terminal illnesses; this has changed significantly. Today, patients not only have a right to their diagnosis, but also to their laboratory results, and many lab tests are available directly to the consumer. The market for DTC tests is booming, with new start ups raising millions of dollars.

FDA regulates DTC tests. Recently, FDA cleared another at-home STI test; the first was authorized in late 2023. The first at-home syphilis test was authorized in 2023.  Interestingly, STI tests are generally considered low-risk (chlamydia is Class I; gonorrhea is Class III; syphilis is Class II and there will be a new syphilis classification under 21 CFR 866.3986). New at home collection devices for HPV tests have also been approved.

Access to reliable, actionable information is of high utility to patients, but tests provide varying levels of both, which is concerning. This has created problems for providers. The American Heart Association recently published guidance for physicians encountering patients with DTC test results. 

People are right to be skeptical - studies show the accuracy of DTC tests to be relatively low and the labeling may not fully explain the test’s limitations. And there are likely DTC tests that should be reviewed by FDA but aren’t.

Clinical utility aside, privacy concerns are rampant regarding DTC test data. Because these tests are paid for out of pocket, they do not fall under HIPAA protections. Data breaches, such as the one 23andme faced, can put personal genetic and health information in the hands of bad actors. And when a DTC company, like 23andme, goes bankrupt, there is well-founded anxiety over the privacy and ownership of data. 

The utility of at-home or DTC tests, particularly in sensitive areas like sexual health, could expand access to important information and significantly aid people in making healthy decisions. But as always, none of this is true if the tests don’t work.