IDDI WEBINAR: From Biomarker to IVD: how to design efficient analytical validation studies

Drug development in many diseases is now shifting toward molecularly targeted treatments that often rely on prognostic and predictive biomarkers for their application. Confronted with such a major breakthrough in the evolution toward personalized or precision medicine, the analytical and clinical validation of biomarkers and their eventual registration as in-vitro diagnostic devices (IVD) has received more attention recently. Contents of the webinar: Focus on the analytical validation of IVDs, the process through which one gains assurance that the data delivered by IVDs are ‘reliably correct’, the prerequisite for IVDs’ clinical use. Introduction to biomarker, IVD and analytical validation terminology. Analytical validation for some of the most important performance characteristics and how these should be established according to the most recent CLSI guidance documents. Precision, linearity and limits of detection and quantification with illustrations of each performance characteristic with analytical validation of Alzheimer’s disease biomarkers. Strengths and weaknesses of the CLSI guidance documents with a focus on the proposed experimental designs and statistical methodologies to analyze the data.