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.