dc.contributor
Institut Català de la Salut
dc.contributor
[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
dc.contributor
Vall d'Hebron Barcelona Hospital Campus
dc.contributor.author
Raicevic Toungouz, Gordana
dc.contributor.author
Kamal, Maud
dc.contributor.author
Gausachs Romero, Mireia
dc.contributor.author
mazzarella, luca
dc.contributor.author
Alessandrello, Rossana
dc.contributor.author
Giacomini, Patrizio
dc.contributor.author
Gonzalo Ruiz, Javier
dc.date.accessioned
2025-10-25T05:39:04Z
dc.date.available
2025-10-25T05:39:04Z
dc.date.issued
2025-09-05T09:19:17Z
dc.date.issued
2025-09-05T09:19:17Z
dc.identifier
Raicevic Toungouz G, Alessandrello R, Giacomini P, Kamal M, Gausachs M, Mazzarella L, et al. Development and implementation of novel liquid biopsy NGS panels via the OncNGS precommercial procurement (PCP) initiative. ESMO Open. 2025 Jun;10(6):105127.
dc.identifier
http://hdl.handle.net/11351/13617
dc.identifier
10.1016/j.esmoop.2025.105127
dc.identifier
001498912800001
dc.identifier.uri
http://hdl.handle.net/11351/13617
dc.description.abstract
Comprehensive genomic profiling; Liquid biopsy; Precommercial procurement
dc.description.abstract
Perfil genòmic complet; Biòpsia líquida; Obtenció precomercial
dc.description.abstract
Perfil genómico complet; Biopsia líquida; Obtención precomercial
dc.description.abstract
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.
dc.description.abstract
This work was supported by the European Union’s Horizon 2020 research and innovation program [grant number 874467].
dc.format
application/pdf
dc.relation
ESMO Open;10(6)
dc.relation
https://doi.org/10.1016/j.esmoop.2025.105127
dc.relation
info:eu-repo/grantAgreement/EC/H2020/874467
dc.rights
Attribution-NonCommercial-NoDerivatives 4.0 International
dc.rights
http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights
info:eu-repo/semantics/openAccess
dc.subject
Càncer - Diagnòstic
dc.subject
Càncer - Aspectes genètics
dc.subject
DISEASES::Neoplasms
dc.subject
Other subheadings::Other subheadings::/diagnosis
dc.subject
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Diagnostic Techniques and Procedures::Clinical Laboratory Techniques::Cytological Techniques::Cytodiagnosis::Biopsy::Liquid Biopsy
dc.subject
CHEMICALS AND DRUGS::Nucleic Acids, Nucleotides, and Nucleosides::Nucleic Acids::Cell-Free Nucleic Acids::Circulating Tumor DNA
dc.subject
ENFERMEDADES::neoplasias
dc.subject
Otros calificadores::Otros calificadores::/diagnóstico
dc.subject
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::técnicas y procedimientos diagnósticos::técnicas de laboratorio clínico::técnicas citológicas::citodiagnóstico::biopsia::biopsia líquida
dc.subject
COMPUESTOS QUÍMICOS Y DROGAS::nucleótidos y nucleósidos de ácidos nucleicos::ácidos nucleicos::ácidos nucleicos libres de células::ADN tumoral circulante
dc.title
Development and implementation of novel liquid biopsy NGS panels via the OncNGS precommercial procurement (PCP) initiative
dc.type
info:eu-repo/semantics/article
dc.type
info:eu-repo/semantics/publishedVersion
