Generic Protocols for Analytical Validation of Tumor-Informed Circulating Tumor DNA Assays for Molecular Residual Disease: BLOODPAC’s MRD Analytical Validation Working Group Consensus Recommendation

BLOODPAC’s MRD Analytical Validation Working Group has published Generic Protocols for Analytical Validation of Tumor-Informed Circulating Tumor DNA Assays for Molecular Residual Disease, a consensus recommendation developed to address the unique analytical challenges of molecular residual disease (MRD) testing. In this setting, tumor-derived DNA is often present at extremely low levels, requiring ultra-high sensitivity methods to ensure reliable detection and reproducible results.

These technology-agnostic protocols provide a standardized baseline framework that can be adapted to any tumor-informed MRD assay, regardless of sequencing technology, panel design, algorithms, or workflow components. By harmonizing approaches to analytical validation, this work aims to support the development of robust, well-characterized MRD assays and promote consistency across laboratories, studies, and clinical applications.

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