Developing a UEMS Position on Direct-to-Consumer Testing (DTCT): Point of view
Birgitte Rode Diness¹
Truls Leegaard²
Matthias Orth³ ORCID: 0000-0003-2881-8384
¹ UEMS Section of Medical Genetics; Copenhagen University Hospital Rigshospitalet, Department of Clinical Genetics, Copenhagen, Denmark
² UEMS Section of Medical Microbiology; Institute of Clinical Medicine, University of Oslo, Norway, and Department of Microbiology and Infection Control, Akershus University Hospital, Norway
³ UEMS Section of Laboratory Medicine; Vinzenz von Paul Kliniken gGmbH, Institut für Laboratoriumsmedizin, Stuttgart, and Medizinische Fakultät Mannheim, Ruprecht Karls Universität Heidelberg, Mannheim, Germany
Corresponding Author: Matthias Orth
Published: 07/08/2026
Abstract
Background
The rapid expansion of direct-to-consumer testing (DTCT) has created a growing market for laboratory analyses performed outside traditional healthcare structures. Although increased public engagement with health and wellbeing is welcome, testing conducted without appropriate medical oversight raises important concerns regarding patient safety, result interpretation, unnecessary medicalisation, and the misuse of healthcare resources.
Objective
This Point of View argues that the Union Européenne des Médecins Spécialistes (UEMS) should develop a clear position regarding DTCT and participate actively in European discussions concerning regulation, patient protection, and medical oversight.
Discussion
Commercial DTCT providers frequently market tests using medical terminology while simultaneously presenting them as lifestyle or wellness products. This blurs the distinction between healthcare and consumer services and may mislead patients regarding the clinical significance of test results. The absence of appropriate medical evaluation, quality-assured interpretation, and follow-up creates risks including false reassurance, unnecessary anxiety, inappropriate investigations, and delayed diagnosis. Regulatory fragmentation across Europe further complicates patient protection, particularly given the cross-border nature of many DTCT services. The authors advocate for harmonised European regulation, mandatory labelling standards, restrictions on misleading medical claims, and stronger recognition of the role of medically qualified laboratory specialists.
Conclusions
The UEMS and the wider medical community should actively engage in developing a coordinated European approach to DTCT. Protecting patients requires clear distinctions between medical diagnostics and commercial wellness testing, stronger regulatory frameworks, and preservation of the essential role of medical laboratory expertise in ensuring safe and clinically meaningful testing.
Keywords
Direct-to-consumer testing; DTCT; laboratory medicine; patient safety; medical oversight; regulation; self-testing; healthcare ethics
Introduction
The expansion of direct-to-consumer testing (DTCT) has created a rapidly evolving commercial market in which individuals may access a wide range of laboratory analyses without involvement of medically qualified healthcare professionals. This development presents both opportunities and substantial risks for patients, healthcare professionals, and healthcare systems.
As medical specialists involved in laboratory diagnostics, the authors emphasise that the primary ethical obligation of healthcare professionals is to protect patients from harm and ensure that tests influencing health-related decisions are safe, meaningful, and interpreted appropriately within a clinical context.
The increasing popularity of DTCT reflects a broader societal shift toward personal responsibility, health awareness, and consumer participation in healthcare-related decisions. Many individuals purchasing these tests do so with positive intentions, seeking to better understand their health and wellbeing. Such engagement should not be dismissed. However, patient curiosity must be accompanied by clarity, quality assurance, and responsible medical guidance.
When laboratory testing is marketed outside established healthcare structures and without appropriate oversight, the risk of harm increases significantly. Commercial incentives may conflict with medical principles designed to protect patients. While healthcare systems are heavily regulated to prevent misleading claims and unsafe practices, commercial “wellness” markets frequently operate under far less restrictive frameworks. The distinction between healthcare and lifestyle products is often deliberately blurred through advertising strategies, social media promotion, and influencer marketing.
This article argues that the UEMS should adopt a formal position on DTCT in order to support patient safety, preserve the integrity of healthcare systems, and promote appropriate European regulation.
Recognising Patient Engagement While Protecting Patients
The authors acknowledge that patient engagement and interest in personal health are positive developments. In some contexts, self-testing and self-collection strategies may provide genuine healthcare benefits.
Validated self-collection approaches, such as human papilloma virus (HPV) self-sampling programmes, may improve access to screening and increase participation rates. Similarly, self-monitoring in chronic conditions such as diabetes empowers patients and supports long-term disease management when performed using medically approved equipment and within structured healthcare systems.
However, these successful examples differ fundamentally from commercial DTCT because they remain integrated within medical frameworks involving quality assurance, clinical oversight, professional interpretation, and appropriate follow-up.
The current DTCT market frequently operates outside these safeguards. Commercial providers often market lifestyle or wellness products using medical terminology while implying clinical relevance that may not be scientifically justified. Some companies present recreational or non-medical testing as personalised health assessment despite lack of validated clinical utility.
The authors also highlight concerns regarding misuse of accreditation terminology. Certain non-medical laboratories obtain accreditation for limited analytical procedures and subsequently imply that the entire testing pathway, including self-collected samples and consumer interpretation, meets medical laboratory standards. This may create false reassurance and undermine trust in legitimate medical laboratory systems.
Opportunities and Risks of Direct-to-Consumer Testing
The consequences of inappropriate DTCT are not theoretical. Even high-quality laboratory tests may produce large numbers of false-positive results when applied within low-prevalence populations. In poorly validated or low-quality DTCT settings, these risks become substantially greater.
False-positive results may trigger unnecessary diagnostic investigations, psychological distress, inappropriate treatment, and additional healthcare costs. False-negative results may delay appropriate medical attention and create dangerous reassurance in situations requiring clinical assessment.
The authors further warn against the increasing medicalisation of healthy individuals driven primarily by commercial incentives rather than evidence-based medical need. Aggressive marketing strategies frequently encourage repeated testing and promote anxiety regarding normal physiological variation.
Such practices may divert healthcare resources away from patients with genuine medical needs and contribute to growing strain on healthcare systems already affected by workforce shortages and increasing demand.
Ethical Responsibilities and the Role of Medical Oversight
A central argument of this Point of View is that laboratory medicine should be understood as a clinical act rather than merely an analytical process.
The value and interpretation of laboratory tests depend fundamentally on clinical context. Appropriate test selection, quality-assured pre-analytical procedures, validated analytical methods, expert interpretation, and responsibility for follow-up are all essential components of safe laboratory medicine.
Within DTCT systems, these safeguards are frequently absent. Commercial marketing may suggest that testing itself is inherently beneficial while omitting discussion regarding limitations, uncertainty, or appropriate interpretation.
The authors argue that medical oversight remains essential because clinicians and laboratory specialists are responsible not only for performing tests, but also for ensuring that testing is medically justified and clinically meaningful.
This responsibility extends beyond individual patients. Misleading or inappropriate testing also affects healthcare professionals across specialties who increasingly encounter patients distressed by non-validated wellness panels, recreational genetic testing, or poorly interpreted laboratory reports.
Confusion as a Central Feature of DTCT Marketing
The article identifies confusion as a defining characteristic of the DTCT business model.
Commercial providers frequently use medical terminology to market non-medical tests, present unvalidated interpretations as personalised health insights, or imply diagnostic value where none exists. In some cases, entirely pseudoscientific methods are marketed as legitimate healthcare products.
Examples cited include bioresonance testing from hair samples for allergy diagnosis and genetic testing purportedly predicting sports aptitude despite lack of scientific validity.
Such practices exploit patient trust and undermine the clarity required for safe healthcare decision-making.
Regulatory and Legislative Challenges
The authors argue that clear and harmonised legislation is urgently required to protect patients and maintain the integrity of healthcare systems.
Consumers should be able to distinguish clearly between:
- Medical diagnostic tests
- Lifestyle or wellness products
- Recreational tests lacking validated clinical relevance
Mandatory labelling requirements comparable to those used in food and cosmetic regulation may help reduce confusion and improve transparency.
The article also emphasises the need for restrictions on misleading medical claims. Commercial providers should not be permitted to imply diagnostic value without appropriate evidence or to use limited accreditation of analytical components to suggest broader medical equivalence.
Regulatory fragmentation within Europe creates additional challenges because DTCT services frequently operate across national borders. While medical devices are regulated at European level through the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), many DTCT services are classified legally as services rather than medical products and therefore remain primarily regulated through national legislation.
This creates opportunities for circumvention of national protections, particularly in sensitive areas such as genetic testing.
Recommendations for the Medical Community
The authors argue that the medical community should actively engage in patient education, regulatory advocacy, and clarification of the distinction between validated medical testing and commercial wellness products.
Non-medical test results should generally not be integrated into healthcare records because unvalidated or poorly interpreted information may influence inappropriate clinical decision-making.
At the same time, medical professionals should support validated self-collection strategies when they are appropriately embedded within clinical pathways and supported by medical oversight.
The article also highlights the importance of communicating the value of medical laboratory expertise. Laboratory medicine involves not only technical analysis, but also clinical interpretation, quality assurance, patient safety, and professional responsibility.
Above all, the authors emphasise the ethical principle of “do no harm” as the guiding framework for discussions surrounding DTCT.
Conclusion
Direct-to-consumer testing is likely to remain an increasingly visible component of the modern health landscape. Public engagement with health and wellbeing is valuable and should be encouraged, but patient curiosity must be accompanied by clarity, quality assurance, and responsible medical guidance.
The rapid growth of DTCT raises important concerns regarding patient safety, misleading marketing, unnecessary medicalisation, false reassurance, and misuse of healthcare resources.
The authors therefore argue that the UEMS should develop and promote a clear European position regarding DTCT. Such a position should support harmonised regulation, transparent communication, appropriate medical oversight, and preservation of the essential role of medically qualified laboratory specialists.
Protecting patients requires not only technical regulation, but also active engagement by the medical profession in ensuring that laboratory testing remains clinically meaningful, ethically responsible, and centred on patient welfare rather than commercial interest
Open Access & Copyright
© 2026 The Authors. Published by the European Medical Specialist Review (EMSR) under the terms of the Creative Commons Attribution 4.0 International License (CC BY 4.0).
How to cite this article
Diness BR, Leegaard T, Orth M. UEMS Should Develop a Position on Direct-to-Consumer Testing (DTCT): Point of view. European Medical Specialist Review. Published 7 August 2026. https://doi.org/10.67452/EMSR.2026.013
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