Certified Reference Materials for Standardization of cfDNA Isolation Recovery in Liquid Biopsy

Reliable quantification of cell-free DNA (cfDNA) in liquid biopsy diagnostics critically depends on unbiased and reproducible isolation workflows. Fragment-length-dependent recovery during isolation represents a major source of pre-analytical bias. This variability limits method validation, interlaboratory comparability, and the reliability of cfDNA measurements in clinical and research laboratories. However, certified reference materials (CRMs) specifically designed to evaluate cfDNA isolation recovery are currently lacking.