Sistema de Salut de Catalunya
Institut Català de la Salut
[Raicevic Toungouz G] Cancer Center, Sciensano (SC), Brussels, Belgium. [Alessandrello R] Agència de Qualitat i Avaluació Sanitàries de Catalunya (AQUAS), Departament de Salut, Generalitat de Catalunya, Barcelona, Spain. [Giacomini P] Fondazione Policlinico Universitario Agostino Gemelli IRCCS, UOSD Medicina di Precisione in Senologia, Rome, Italy. Alleanza Contro Il Cancro (ACC), Rome, Italy. [Kamal M] Department of Drug Development & Innovation, Institut Curie (IC), Paris, France. IHU PRISM National PRecISion Medicine Center in Oncology, Gustave Roussy, France. [Gausachs M] Institut Català d’Oncologia (ICO), L’Hospitalet de Llobregat, Barcelona, Spain. [Mazzarella L] Alleanza Contro Il Cancro (ACC), Rome, Italy. Department of Experimental Oncology, European Institute of Oncology (IEO) - IRCCS, Milan, Italy. [Gonzalo J] Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain
Vall d'Hebron Barcelona Hospital Campus
2025-09-05T09:19:17Z
2025-09-05T09:19:17Z
2025-06
Comprehensive genomic profiling; Liquid biopsy; Precommercial procurement
Perfil genòmic complet; Biòpsia líquida; Obtenció precomercial
Perfil genómico complet; Biopsia líquida; Obtención precomercial
Background Circulating tumor DNA (ctDNA) analysis is transforming oncology, but challenges such as insufficient analytical sensitivity, difficult variant interpretation, suboptimal turnaround time, limited deployment flexibility, and high costs hinder its broader adoption and raise concerns about reimbursement sustainability across European health care systems. Materials and methods To address these challenges, we created the OncNGS consortium, comprising academic, public, and private hospitals (buyers’ group) and several supporting entities, to run a European precommercial procurement (PCP) initiative. The consortium defined ctDNA diagnostic testing requirements, conducted an open market consultation, and launched a call for tender. Suppliers were invited to develop an end-to-end, Conformité Européenne In Vitro Diagnostic (CE-IVD)-compliant solution integrating wet laboratory, dry laboratory, and reporting workflow in a single procedure, offering short turnaround time and reasonable cost. Results The OncNGS consortium defined criteria for a versatile, modular, cost-effective solution, deployable centrally or on-site, and adaptable to advancements in precision oncology. Launched in July 2022, the tender attracted seven companies, with four selected for phase I—OncNGS solution(s) design. From these, three advanced to phase II—prototyping. Ultimately, two contractors were awarded contracts for phase III to assess the clinical performance of their prototypes. Conclusions By leveraging the PCP approach, OncNGS aims to deliver innovative, affordable solutions to standardize ctDNA testing and reporting across European Union countries, improving diagnostic and therapeutic strategies for oncology patients.
This work was supported by the European Union’s Horizon 2020 research and innovation program [grant number 874467].
Article
Published version
English
Càncer - Diagnòstic; Càncer - Aspectes genètics; Biòpsia; DISEASES::Neoplasms; Other subheadings::Other subheadings::/diagnosis; ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Diagnostic Techniques and Procedures::Clinical Laboratory Techniques::Cytological Techniques::Cytodiagnosis::Biopsy::Liquid Biopsy; CHEMICALS AND DRUGS::Nucleic Acids, Nucleotides, and Nucleosides::Nucleic Acids::Cell-Free Nucleic Acids::Circulating Tumor DNA; ENFERMEDADES::neoplasias; Otros calificadores::Otros calificadores::/diagnóstico; TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::técnicas y procedimientos diagnósticos::técnicas de laboratorio clínico::técnicas citológicas::citodiagnóstico::biopsia::biopsia líquida; COMPUESTOS QUÍMICOS Y DROGAS::nucleótidos y nucleósidos de ácidos nucleicos::ácidos nucleicos::ácidos nucleicos libres de células::ADN tumoral circulante
Elsevier
ESMO Open;10(6)
https://doi.org/10.1016/j.esmoop.2025.105127
info:eu-repo/grantAgreement/EC/H2020/874467
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
