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 the number of diseases for which therapies are being developed. Frequently, clinical laboratories have biomarker assays used in disease treatment that are now being evaluated for use in clinical trials to demonstrate the safety and efficacy of new therapies, and in some cases the biomarkers act as a number of different study endpoints, including predictive and prognostic, while some aspire to be surrogate endpoints.
