From Biomarker to In-Vitro (Companion) Diagnostic Device: How to Design and Conduct Efficient Analytical Validation Studies in Accordance with CLSI Guidelines

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.

This webinar will focus on the analytical validation of in-vitro diagnostic devices, the process through which one gains assurance that the data delivered by in-vitro diagnostic devices are ‘reliably correct’, the prerequisite for in-vitro diagnostic devices’ clinical use. We will highlight the fundamental link between analytical validation and the clinical context and anticipated clinical use of the in-vitro diagnostic devices.

This webinar will start with an introduction to biomarker, in-vitro diagnostic devices and analytical validation terminology. Then the presentation will outline the analytical validation in practice for some of the most important performance characteristics and how these should be established according to the most recent CLSI guidance documents. Next, the webinar will cover precision, linearity and limits of detection and quantification and illustrate each performance characteristic with analytical validation of Alzheimer’s disease biomarkers. Strengths and weaknesses of the CLSI guidance documents will be discussed, with a focus on the proposed experimental designs and statistical methodologies to analyze the data.

In practice, analytical validation consists of experimental work, yielding measurements that are analyzed to demonstrate the analytical performance characteristics of the product. Performance characteristics include, amongst others, precision, interference, analytical specificity, linearity, and limits of detection and quantification. For most performance characteristics, the Clinical and Laboratory Standards Institute (CLSI) has developed clinical laboratory testing standards based on input from and consensus among industry, government, and health care professionals. The FDA has recognized consensus standards issued by CLSI, and adhering to those standards for analytical validation is expected to simplify and streamline the review process by the FDA.

Speakers

Elisabeth (Els) Coart, PhD, Senior Research Biostatistician, IDDI

Elisabeth (Els) Coart, PhD, is senior research biostatistician and IDDI’s expert in analytical and clinical validation of in-vitro diagnostic devices. Els has a strong background in assay development combined with 9 years’ experience as statistician for biotech and diagnostic industries. She has a longstanding interest in Alzheimer’s disease (AD) biomarkers and presents IDDI’s work in this field at AD symposia.

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Hugo Vanderstichele, PhD, Co-Founder and Director Assay Development, ADx NeuroSciences

Hugo Vanderstichele, PhD, is Co-Founder and Director Assay Development of ADx NeuroSciences (Belgium) which has the mission to provide first-in-class technology platforms for the In Vitro Diagnosis market to support patient management. He is also founder of Biomarkable bvba. Hugo is an active member of international consortia aiming at assay standardization and qualification of protein biomarker. His deep experience in protein assay development has created value for the health care industry in different disease domains. He is an author of several patent applications and a large number of publications

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