Guidance for the Regulation, Evaluation, Marketing and Monitoring of DTCTs: GUIDE-DTCTs

Shopping basket filled with various boxes of tests you can buy in supermarkets and chemists.

Direct To Consumer Tests (DTCTs) have the potential for significant positive impacts on individuals, populations and the health economy through increasing autonomy, acceptability and expediating diagnoses. However, DTCTs also have considerable potential to cause harm.

In the absence of UK guidance or regulation DTCTs may exploit the worried well, deviate from evidence-based testing guidance and worsen existing NHS capacity issues as consumers seek support with test interpretation from healthcare professionals.

Great Britain (GB) is in a period of transition from EU regulations towards the development of GB specific medical devices regulation. This creates an opportunity to develop new regulation and policy to avoid the potential harm and financial burden to the public and NHS of the current DTCT landscape. 

GUIDE-DTCTs is an 18-month project funded by Cancer Research UK (CRUK). The project will convene a multidisciplinary stakeholder group representing the medical and pharmaceutical professions, regulatory bodies, manufacturers, retailers, policy makers and the public. The stakeholder group will oversee a programme of research to develop evidence requirements for risk classification of DTCTs, standards for labelling, including reporting of tests claims, instructions for use at the point of sale and interpretation of test results. Proposed evidence requirements and standards will feed into the development of new regulation policies.

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For more information about the project and other queries please email

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