From Biomarkers to In-vitro Companion Diagnostic Device

October 19, 2015

IDDI organized a webinar on the analytical validation of in-vitro diagnostic devices entitled ‘From Biomarkers 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 focused 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. The speakers highlighted the fundamental link between analytical validation and the clinical context and anticipated clinical use of the in-vitro diagnostic devices.
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From Biomarkers to In-vitro Companion Diagnostic Device: How to design and conduct efficient analytical validation studies in accordance with CLSI guidelines

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  • This webinar:
    • Started with an introduction to biomarker, in-vitro diagnostic devices and analytical validation terminology
    • Outlined 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
    • Covered precision, linearity and limits of detection and quantification and illustrate each performance characteristic with analytical validation of Alzheimer’s disease biomarkers
    • Discussed strengths and weaknesses of the CLSI guidance documents with a focus on the proposed experimental designs and statistical methodologies to analyze the data

Speakers:

  • Elisabeth (Els) Coart, PhD, Senior Research Biostatistician and IDDI’s expert in analytical and clinical validation of in-vitro diagnostic devices
  • Hugo Vanderstichele, PhD, Co-Founder and Director Assay Development, ADx NeuroSciences
Presentation of the Webinar: From Biomarkers to In-vitro Companion Diagnostic Device

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