Marketing of laboratory tests direct to the public

On the 11th September 2023, the ACB was a co-signatory to a letter sent to Secretary of State for Health and Social Care, Rt Hon Steve Barclay MP, regarding the unregulated marketing of diagnostic tests.

In conjuction with the Institute of Biomedical Science, the Royal College of Pathologists and the Royal College of General Practitioners, we have asked the Government to supply appropriate support and regulation of this market.

Dear Secretary of State,

Subject: Marketing of laboratory tests direct to the public

Diagnostic tests are being marketed to the public in ways that create patient safety issues.

Currently, the diagnostics testing market lies outside the remit of the Medicines and Healthcare Regulatory Agency (MHRA) and the availability and use of these unregulated diagnostic tests and testing kits are a cause for concern.

While the use of self-testing kits for monitoring long term conditions is evidence-based and has our support, the unregulated marketing of diagnostic tests has detrimental effects on the targeted consumers, and other patients.

In our healthcare services, diagnostic tests and testing kits are selected, executed, and interpreted, by highly qualified and regulated professionals. This ensures safe, high-quality results that are interpreted and reported on correctly.

The main issues with an unregulated diagnostic testing market:

  • Capacity issues within the NHS are enabling the exploitation of the ‘worried well’ – selling anxious people data without providing them with any professional support, and often no interpretation of their data. In turn, this often leads to further strain on capacity as the patient seeks support or interpretation.
  • There is a lack of evidence regarding test development and patient instruction. For example, there is a danger that the tests are conducted without the quality assurance which is a hallmark of medical laboratory practice throughout the NHS and private healthcare (e.g. to ISO15189:2022 standards).
  • The marketing strategy for some tests includes a refund for normal results. Incentivising abnormal results leads to unwarranted and unnecessary workload for both primary and secondary care because of the need for clinical confirmation.

We welcome improved patient access to diagnostic results using innovative technology. However, leaving the commercial sector of diagnostic testing unregulated harms healthcare services and the public.

We are now asking Government to supply appropriate support and regulation for this market. We look forward to supporting you in delivering this.