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Technical recommendations from a large-scale French Delphi consensus: A step toward European harmonization of ctDNA
Alexandre Harlé1, Léa Payen2, Alexandra Lespagnol3
1Service de Médecine de Précision et Recherche Translationnelle, Institut de Cancérologie de Lorraine, CNRS UMR 7039 CRAN, Université de Lorraine, Vandoeuvre-Lès-Nancy, France.
European Journal of Cancer (Oxford, England : 1990)
|May 26, 2026
Summary
Standardizing circulating tumour DNA (ctDNA) testing is crucial for precision oncology. This consensus provides 37 recommendations for technical standardization of ctDNA analysis to improve reproducibility and clinical reliability.
Area of Science:
- Oncology
- Molecular Diagnostics
- Genetics
Background:
- Circulating tumour DNA (ctDNA) testing is vital for precision oncology.
- Technical variability in ctDNA analysis hinders reproducibility and clinical reliability.
Purpose of the Study:
- To establish technical standardization for ctDNA analysis through a European Delphi consensus.
- To address heterogeneity in liquid biopsy testing across laboratories.
Main Methods:
- A European Delphi consensus initiative involving 39 high-volume molecular platforms.
- Iterative anonymous surveys and live voting to reach agreement on recommendations.
Main Results:
- 37 recommendations (≥80% agreement) were established for ctDNA analysis phases (pre-analytical, analytical, bioinformatics, post-analytical).
- Key recommendations include mandatory unique molecular identifiers (UMIs), double centrifugation, positive controls, leukocyte preservation, and explicit result reporting.
- Recommendations show >90% alignment with international guidelines, offering prescriptive specifications for critical steps.
Conclusions:
- The consensus provides a framework to harmonize ctDNA testing across Europe, enhancing confidence in liquid biopsy results.
- This standardization supports routine diagnostic and theragnostic applications in oncology.
