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Abstract
Objective To describe recommendations applicable to new diagnostic and screening tests brought to market in the UK as of 01 June 2023; and extract agreements, disagreements and gaps.
Design Extant regulations, recommendations and guidelines for new diagnostic and screening tests applicable to new products placed in the UK market as of 01 June 2023. Non-English and references not applicable to new tests seeking market access in the UK on 01 June 2023 were excluded.
Data sources PubMed, Web of Science Core Collection and Scopus; grey literature via EuropePMC and Google, government regulations and guidelines, and relevant professional societies. References of relevant included data were scanned for includable articles. Resultant data were thematically analysed and presented as a narrative scoping review.
Eligibility for selecting studies PubMed, Web of Science Core Collection and Scopus were searched from 1/1/2018 for regulations, guidelines or recommendations for in vitro diagnositic tests as applied to the UK on 1/6/23. Relevant papers also had references searched.
Results 943 items were initially identified with 892 excluded. Reference searching located a further 31 papers and 82 items were analysed. Seven themes were identified: regulation, companion diagnostics and lab developed tests, safety and evidence, test specific recommendations, data, innovation and recommendations for patients/the public. Wide agreement included the need to reduce bureaucracy and duplication; to mitigate to avoid unintended consequences of In Vitro Diagnostic Regulation. Disagreement over whether high-quality evidence should precede regulatory approval, or could be gathered as part of postmarketing surveillance emerged.
Conclusions Industry, regulators, academics, patients representing a variety of views, should collaborate to work through areas of disagreement.
- Early Diagnosis
- Conflict of Interest
- Delivery of Health Care
- Evidence-Based Practice
- Health Care Quality, Access, and Evaluation
Data availability statement
No data are available.
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- Early Diagnosis
- Conflict of Interest
- Delivery of Health Care
- Evidence-Based Practice
- Health Care Quality, Access, and Evaluation
Data availability statement
No data are available.
Footnotes
X @mgtmccartney
Contributors Concept: PDD, FS, MMcC. Method: PDD, FS, MMcC, JD. Data extraction and PRISMA process: MD, OK with PDD, FS, MMcC. Thematic analysis: MMcC, FS, PD with OK and MD. First draft MMcC with contributions from all. Guarantor: MMcC.
Funding MS and OK were funded with summer studentships by the University of St Andrews School of Medicine.
Competing interests MMcC has written about hazards of early diagnosis and screening tests, some of this has been paid journalism. PDD, FS, JD and MMcC are on the Scientific Committee of the Evidence Based Early Diagnosis conference first held in 2024 and it will likely be held again.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
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