In the bioanalytical laboratory, we often receive requests for biomarker assays that come with little to no context as to what questions the biomarker data are expected to answer. In its simplest form the request comes as ‘do you have a validated assay for biomarker X?’ When faced with this situation, how should we proceed? How should we answer the question?
In a time where everything around us moves fast, it is important to “make haste, slowly.” Only by making time to understand the background to the request will we have the confidence that the biomarker data our laboratories produce are fit for their intended purpose.
Here we will review a number of case studies where biomarker assays were requested with insufficient information on context-of use (CoU). We will walk through the research and conversations that were needed to understand the biology of the biomarker, the mechanism of action of the drug and how the biomarker data would be used.
By taking time to perform this diligence, we are able to adopt a suitable bioanalytical strategy for our biomarkers where the appropriate level of assay performance is understood, ultimately allowing us to develop safe, effective medicines in the most resource-efficient manner.
Ask key stakeholders the right questions to define COU and craft specific COU statements to support drug development programs at all stages
Determine key considerations for COU-driven assay characterization and validation and evaluate existing assays for their suitability for proposed COUs
Understand how to iterate an assay to meet evolving COUs