Translational and Clinical Science Community

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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Hi @Wendy Adamowicz,

Thank you for bringing this to our attention. Emerging and multiplexing bioanalytical and biomarker technologies, such as NULISA, Olink, and SPEAR Bio technologies are gaining increasing interest across the field. A similar topic was also discussed at the 2023 WRIB meeting, where I served as a session chair, and the key insights were captured in a white paper. "It is important to distinguish between the semi-quantitative vs. quantitative analysis for high-plex proteomics technologies. For QCs, start with the system suitability and assay controls for the large panel followed by applying QC samples for specific decision-making quantitative protein biomarker analysis." (Kholmanskikh et al, 2023 Bioanalysis, https://www.tandfonline.com/doi/full/10.1080/17576180.2024.2340961).

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Hiroshi Sugimoto
Director
Takeda
Cambridge MA
[email protected]

Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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