On-Demand Webinar: Exploratory Biomarker Testing – to Qualify or Validate the Assay?

There is much confusion in the world of biomarker testing when it comes to ‘assay qualification’ vs ‘assay validation’ because the terms are not strictly defined. Both approaches seek to prove that the test is suitable for its intended purpose, but they differ regarding the depth and robustness of the parameters evaluated and the number of replicates performed for each parameter.

With the question ‘should we qualify or validate an exploratory biomarker assay before sample testing?’ in mind, the goal of this presentation is to define the latest scientific and regulatory considerations for the analytical validation of assays for fluid-based biomarkers used in the qualification of drug development tools (DDTs). Topics to be discussed include: considerations for assay design; technology selection, including singleplex and multiplex ligand binding and immunometric assays; optimization of pre-analytical factors; core assay performance expectations; and setting minimally acceptable assay performance criteria.