ArticleBioanalysis2024
A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays.
Article in Bioanalysis, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 10 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Who cites it
10 citing papers in PubMed.
- Proteomic Biomarker Discovery in Breast Cancer: Advances, Challenges, and Translational Prospects.Journal of biochemical and molecular toxicology · 2026Review
- Urolithins in clinical translation: from gut microbial metabolites to precision interventions.Frontiers in nutrition · 2026Review
- Development and validation of a method for quantitation of CTx-1 for the assessment of biosimilarity of FKS518, a denosumab biosimilar.Bioanalysis · 2025Article
- Why is Biomarker Assay Validation Different from that of Pharmacokinetic Assays?The AAPS journal · 2025Article
- Review
- Article
- Recent discussions and proposals on challenging the 3-tier immunogenicity testing strategies from the European bioanalysis forum.Bioanalysis · 2025Article
- Feedback from the 10th European Bioanalysis Forum Young Scientist Symposium and from the Science Café discussions on sustainability in bioanalysis.Bioanalysis · 2025Article
- Feedback from a workshop by the European Bioanalysis Forum on assay validation requirements forBioanalysis · 2025Article
- The European Bioanalysis Forum recommendation on establishing appropriate drug tolerance levels in antidrug antibody assays.Bioanalysis · 2024Article
Corrections and comments
- Erratum issuedCorrection.2024
Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The European Bioanalysis Forum, alongside key industry stakeholders, has been driving the discussions around the implementation of context-of use for biomarker assays to ensure that these assays are validated appropriately depending on their purpose. Insights into understanding why the implementation of context-of-use in assay strategies has also shown that the key stakeholder, or requester for the biomarker data, is responsible for providing the context-of-use statement for all biomarker assay requests. Experts from across the industry haves repeatedly sought a cross-industry recommended format in which the context-of-use statement could be provided. In this manuscript, the European Bioanalysis Forum suggests a format for this.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.