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

Cowan KJ, Kunz U, Blattmann P et al. | Bioanalysis, 16(16), 835–842, (2024) Keywords: • biomarkers • biomarker assay validation • context-of-use statement • regulatory guidance 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...