Dear Translation & Clinical Science and Discovery & Preclinical Research Communities (Formerly Biomarkers and Precision Medicine),
With multi-parameter biomarker platforms such as NULISA and Olink becoming increasingly mainstream, questions regarding the appropriate level of validation are becoming more relevant. We currently apply ICH M10 parameters to "validate" endogenous or target biomarkers and other novel modalities. As these RUO panels become more routinely used, I can foresee a time when data generated from these assays-whether standard or custom panels-may be incorporated into inclusion criteria, treatment decisions, and/or regulated bioanalytical applications and may expect a similar "validation" approach.
Has anyone else encountered similar considerations? We have a few initial ideas and would be very interested in hearing others' perspectives. @Hiroshi Sugimoto would it make sense to consider this as a future focus topic, potentially with the goal of developing a white paper or similar publication?
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Wendy Adamowicz, M.S.
Principal Scientist
PPD Clinical Research, ThermoFisher Scientific
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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