Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Predictive biomarker

Biomarker (BM) • A characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention. [BEST*] • We are concerned with the subset of ‘analytes’ Predictive biomarker • A biomarker used to identify individuals who are more likely than similar individuals without the biomarker to experience a favourable or unfavourable effect from exposure to a medical product or an environmental agent. [BEST*] * BEST (Biomarkers, EndpointS, and other Tools ) Resource. FDA-NIH Biomarker Working Group

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Personalised medicine definition

• “a medical model using characterization of individuals’ phenotypes and genotypes (e.g. molecular profiling, medical imaging, lifestyle data) for tailoring the right therapeutic strategy for the right person at the right time , and/or to determine the predisposition to disease and/or to deliver timely and targeted prevention”

• “notes that the development and implementation of personalised

medicine goes hand-in-hand with the development of relevant diagnostics”

The Organisation for Professionals in Regulatory Affairs

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