Ever had a patient bring in a packet of test results you never ordered and countless questions on results for tests you’ve never even heard of? If not, prepare yourself.
Direct-to-consumer (DTC) lab testing began modestly in 1977 when the FDA approved at-home pregnancy tests. Over the last 50 years, it has evolved into a multi-billion-dollar industry offering hundreds of tests without a prescription. Some companies even sell panels of hundreds of tests at once, promising to screen thousands of diseases. Social media influencers like anti-aging mogul Bryan Johnson and Stanford neuroscientist Andrew Huberman promote frequent and expansive testing for so-called “health optimization.”
In a recent survey, 18.6 percent of U.S. adults report making an online purchase for lab testing services, more than mental health counseling (14.1 percent) and telehealth appointments (11.5 percent). In 2025, direct-to-consumer lab testing was a 3.75-billion-dollar industry, and it is expected to more than double by 2035.
Several factors might collectively explain this exponential rise. Social media and influencers advertise and promote these tests and companies, capitalizing on mistrust of doctors and the medical system as a whole that has increased since the COVID pandemic. Thanks to the internet, access to DTC testing is just a few clicks away. Medicaid cuts and the erosion of employer-based health insurance coverage with high deductibles are also likely playing a role. People are buying the idea that regular and comprehensive testing will catch disease early, optimize health, and fill gaps left by their primary care team (if they have one). From the perspective of a consumer, it certainly makes sense why this industry has exploded. But is DTC lab testing actually a good thing for our patients?
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I have concerns. While some DTC companies like LabCorp OnDemand use the same labs trusted by doctors’ offices, others operate with minimal, if any, medical oversight. All labs must comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA), though state laws vary greatly. Despite recent attempts to expand FDA oversight, these labs remain mostly unregulated. Since these tests are marketed as wellness products rather than clinical diagnostics, they face significantly less regulatory scrutiny. A 2023 study found that over half of DTC test products did not report analytical performance or laboratory accreditation.
Privacy is another concern. Over half of DTC companies indicate that they use data for internal research or “third-party sharing.” Some even disclose sharing information with insurers and other commercial entities. Even worse, less than half of DTC companies report HIPAA compliance.
In summary, consumers end up paying for possibly inaccurate results which might then be sold for profit and potentially misused.
Treatment of abnormal results varies by company. Consumers are sometimes sent a health report with explanations of their results, sometimes they are sold supplements and subscription services, and sometimes they are offered telemedicine appointments with medical providers to explain the results. Almost always, the consumer is told to discuss the results with their primary care doctor, ultimately placing the burden of the possibly inaccurate testing on a clinician who did not order these tests in the first place.
Liability is another major concern. Nearly all DTC companies include disclaimers of warranty and limitation of liability. Who ends up liable for these tests? It depends on state law and the practice of the DTC company. In some situations, the doctor notified of the test results becomes liable for them.
In medical training, we are taught to only order testing if the result will change your management of the patient and to always know what to do if the test result is abnormal. Patients have no such guidance when adding tests to their online cart. A study of DTC screening tests found that only 12 percent were recommended by evidence-based guidelines in targeted populations and none were recommended for the general population. With all of this unnecessary testing, false positives are inevitable. A 2026 analysis estimated that the largest DTC panel would generate nearly 10 expected false-positive results per healthy consumer.
Consequently, ordering a needless test can easily result in harm to the patient through medication side effects, invasive procedures, added testing, and additional stress and anxiety. And when doctors become liable for the results of tests they did not recommend or order, they are also undeniably harmed.
Previous legislation has tried to address this issue. The VALID Act was first drafted in 2018, seeking to increase FDA oversight over these types of companies. Despite bipartisan support, it has never progressed to law. The FDA itself even attempted to make a rule in 2024 to increase oversight over these companies, but the rule was challenged and vacated by the court in 2025. In terms of liability, there are no current laws to protect physicians. Most states actually focus laws on assigning liability, not dismissing it. And with DTC company disclaimers easily offloading responsibility, physicians can easily become liable for results.
How do we as a medical community respond to the boom in DTC testing? First and foremost, we must support legislation to regulate these companies and shield physicians from liability for tests that we never ordered. We should not only warn patients about the dangers of this industry, but also listen to patients and why they may want specific tests. Walk the patient through the indications for testing and how the results might (or might not) change how you treat them. Explain that testing can be inaccurate and ultimately harmful if used irresponsibly. Strengthen the provider-patient relationship and engage in shared decision-making. If a patient insists on having a test, it is better to have their primary doctor interpret the results and implications rather than a telehealth provider who does not know the patient or have incentives to keep them healthy.
Joseph Phelan is a family physician.
