Sistema de Salut de Catalunya
Institut Català de la Salut
[de Jager VD] Department of Pathology and Medical Biology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands. [Giacomini P] UOSD Medicina di Precisione in Senologia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy. Member of the European Liquid Biopsy Society (ELBS) ctDNA Working Group, Hamburg, Germany. [Fairley JA] GenQA, Department of Laboratory Medicine, NHS Lothian, Nine, Edinburgh Bioquarter, Edinburgh, United Kingdom. [Toledo RA] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Patton SJ] EMQN CIC, Unit 4, Enterprise House, Manchester Science Park, Pencroft Way, Manchester, United Kingdom. [Joosse SA] Department of Tumor Biology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Mildred Scheel Cancer Career Center HaTriCS4, University Medical Center Hamburg-Eppendorf, Hamburg, Germany
Vall d'Hebron Barcelona Hospital Campus
2025-04-29T12:20:34Z
2025-04-29T12:20:34Z
2025-04
Consensus; Liquid biopsy; ctDNA test
Consenso; Biopsia líquida; Prueba de ADNct
Consens; Biòpsia líquida; Prova d'ADNct
The implementation of circulating tumor DNA (ctDNA) in the diagnostic routine may enable non-invasive predictive biomarker testing and treatment optimization in patients who lack a suitable tumor specimen, have failed previous molecular analysis or are clinically ineligible for (re-)biopsy procedures. As the interpretation and reporting are more complex for ctDNA than conventional tissue-based NGS, there is a need for specific guidelines. These will offer support for the reporting of ctDNA test results and will facilitate optimal communication of liquid biopsy findings between diagnostic laboratories and the medical oncology team. Aiming to generate guidelines based on real-world experiences and broad perspectives, we organized a European Liquid Biopsy Society (ELBS) ctDNA workshop, in which forty-four experts and key stakeholders from different molecular diagnostics laboratories, oncology and pathology departments, as well as an IVDR specialist, convened to address significant challenges associated with the reporting of liquid biopsy test results. This report delineates the resulting consensus recommendations for ctDNA test reporting with underlying rationale and background information.
This study was funded by the EU project CAN.HEAL, grant n. 101080009 (KP, SAJ, PG). The views and opinions expressed are those of the authors only and do not necessarily reflect those of the European Union or the European Commission. Neither the European Union nor the European Commission can be held responsible for them.
Article
Published version
English
Càncer - Diagnòstic; Càncer - Aspectes genètics; Biòpsia; Decisió, Presa de; CHEMICALS AND DRUGS::Nucleic Acids, Nucleotides, and Nucleosides::Nucleic Acids::Cell-Free Nucleic Acids::Circulating Tumor DNA; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Diagnostic Techniques and Procedures::Clinical Laboratory Techniques::Cytological Techniques::Cytodiagnosis::Biopsy::Liquid Biopsy; DISEASES::Neoplasms; Other subheadings::Other subheadings::/diagnosis; PSYCHIATRY AND PSYCHOLOGY::Behavior and Behavior Mechanisms::Psychology, Social::Group Processes::Consensus; COMPUESTOS QUÍMICOS Y DROGAS::nucleótidos y nucleósidos de ácidos nucleicos::ácidos nucleicos::ácidos nucleicos libres de células::ADN tumoral circulante; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::técnicas y procedimientos diagnósticos::técnicas de laboratorio clínico::técnicas citológicas::citodiagnóstico::biopsia::biopsia líquida; ENFERMEDADES::neoplasias; Otros calificadores::Otros calificadores::/diagnóstico; PSIQUIATRÍA Y PSICOLOGÍA::conducta y mecanismos de la conducta::psicología social::procesos de grupo::consenso
Elsevier
eBioMedicine;114
https://doi.org/10.1016/j.ebiom.2025.105636
Attribution 4.0 International
http://creativecommons.org/licenses/by/4.0/
