Evolving our thinking on biomarker assay validation: are we ready for the next leap?

[...]over the past few years, the topic of analytical validation of methods to measure biomarkers has been hotly debated, with scientists and regulators alike wrestling with how best to define expected performance criteria for biomarker assays. Critical takeaways from that meeting included: clarification that biomarker assays should be approached scientifically in their own right, with evaluations that focus on the measurement of endogenous analyte; highlighting the limitations of spike recovery experiments and the foundational nature of parallelism assessments; and building an understanding that some biomarker applications would require analytical criteria that would be even more stringent than those applied to PK assays (4). [...]biomarker assays should be assessed in context. The biomarker scientist must assume responsibility for being the critical judge of what level of assay performance is required to meet a given COU. [...]to be a successful biomarker scientist, one must demand COU.