Evidence-Based Guidance and Expert Recommendations to Address Pre-analytical Variability in Urine Cell-free DNA Analysis.

Authors

Sarah Rothberg Greytak, Muhammed Murtaza, Kelly Bonner Engel, Philip H Abbosh, Maria E Arcila, Karol Bomsztyk, Viswam S Nair, Ying-Hsiu Su, Anne Westbrook, Claire Robustelli, Abhi K Rao

Published in

The Journal of molecular diagnostics : JMD. Nov 12, 2026. Epub Nov 12, 2026.

Abstract

Cell-free (cfDNA) analysis of urine specimens has shown great promise as a non-invasive means for biomarker detection in cancer patients. However, the transition from experimental to clinically viable assays has been hindered by low sensitivity and low reproducibility among studies. The accurate assessment of urine cfDNA is critically affected by preanalytical handling of the urine specimen. The recommendations developed by a National Cancer Institute (NCI) multidisciplinary working group include strategies to mitigate the impact of preanalytical factors on urinary cfDNA endpoints. Through review of published literature and experience-based discussions, the working group developed an NCI Biospecimen Evidence-based Practice (BEBP) document for Cell-free DNA: Urine Collection and Processing, adaptable, fit-for-purpose guidance that implements a data-driven, decision-making approach. Like other published BEBPs, this BEBP contains step-by-step procedural guidelines, as well as summaries of the literature and expert recommendations on which they are based. Recommendations in the BEBP are applicable for the study of transrenal cfDNA and cfDNA originating from the genitourinary tract and are suitable for implementation in research and clinical settings ranging from large institutions to resource-limited laboratories. The findings, along with the BEBP, can serve as a template to create evidence-based, standard operating procedures to improve the sensitivity and reproducibility of urinary cfDNA assays.

PMID:
43020198
Bibliographic data and abstract were imported from PubMed on 13 Nov 2026.

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