On January 21 of this year, the FDA issued the long-awaited guidance on bioanalytical method validation for biomarkers (BMVB), which replaces the 2018 FDA BMV. The 2025 BMVB guidance recognizes that analytical validation of assays that measure biomarkers differs from the validation of assays that measure drug concentrations (PK). However, the new biomarker guidance points to PK method validation (via ICH M10) as the starting point for the analytical validation of biomarker assays. It also acknowledges that many aspects of ICH M10 cannot be directly applied to different bioanalytical platforms, and different characteristics should be considered, justified, and reported accordingly. The AAPS Biomarkers and Precision Medicine Community Leadership Team interprets this biomarker guidance as not providing any substantial changes from that contained in the original 2018 FDA BMV. This new guidance is consistent with the long-standing view of the biomarker community, specifically that 1) there are differences between PK and biomarker assays which impact analytical method validation strategies, 2) the FDA's fit-for-purpose approach should be used considering the biology of the biomarkers and different analytical characteristics to ensure that the data are reliable, and 3) the assay parameters tested and the approach taken for biomarker method validation should always exactly support the biomarker's proposed Context of Use (COU). We will continue to stress the importance of implementing a fit-for-purpose analytical validation approach that supports the COU.
The guidance can be accessed through the link below on the HHS website:
2025 FDA Biomarkers Guidance (Level 2)
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Karen Quadrini, PhD
Director, Clinical Biomarkers
Prothena Biosciences
Brisbane, CA
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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