Considerations for drug development biomarker assays in the clinical laboratory

Arnold M, Allinson J & Piccoli S | Bioanalysis, 15(10), 533-536, (2023) Keywords: • biomarkers • BMV • CAP • CLIA • clinical laboratory • context of use • drug development • regulations • US FDA • validation Of late, the phrase ‘context of use’ (COU) has become widely used to describe the performance characteristics required in a biomarker assay used in drug development programs. In clinical laboratories, including those supporting clinical trials, biomarker assays have been established to support the medical community in the diagnosis, treatment and monitoring of patients with various diseases. Advances in therapeutic modalities has expanded...