A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays

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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Publication Details

Journal
Bioanalysis
Published
2024-08-05
DOI
https://doi.org/10.1080/17576180.2024.2376436
Citations
9
Primary Topic
Biosimilars and Bioanalytical Methods
Type
article
Field-Weighted Citation Impact
2.16
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A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays

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A European Bioanalysis Forum recommendation for requiring a context-of-use statement for successful development and validation of biomarker assays

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article en
9 citations

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.

BioanalysisVol. 16(16)
Roche (Switzerland) (CH), Boehringer Ingelheim (Germany) (DE), Merck KGaA, Darmstadt (Germany) (DE), Novo Nordisk (Denmark) (DK), LabCorp (United States) (US), PLx Pharma (United States) (US), Bioanalytica (Switzerland) (CH), Charles River Laboratories (United Kingdom) (GB), Toscana Biomarkers (Italy) (IT), Celerion (United States) (US), Charles River Laboratories (Germany) (DE), Institute of Immunology (HR), Idorsia (Switzerland) (CH), Idera Pharmaceuticals (United States) (US), Nuvisan (Germany) (DE), PharmacoGenetics (China) (CN), Boehringer Ingelheim (Australia) (AU), Idiap Research Institute (CH), World Economic Forum (CH)
Openalex Percentile: Top 12%
Biosimilars and Bioanalytical Methods
2.16
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