Please use this identifier to cite or link to this item: https://hdl.handle.net/2445/222245
Title: Development and implementation of novel liquid biopsy NGS panels via the OncNGS precommercial procurement (PCP) initiative
Author: Raicevic Toungouz, Gordana
Alessandrello, Rossana
Giacomini, Patrizio
Kamal, Maud
Gausachs Romero, Mireia
Mazzarella, Luca
Sujobert, Pierre
Frigè, G.
Alay, Ania
Planchon, Julien M.
Blau, O.
Mias Carballal, Montserrat R.
Antoine-Poirel, Hélène
Nadal, Ernest
Bullinger, Lars
Hebrant, Aline
Servant, Nicolas
D’haene, Nicky
Aftimos, Philippe
Silkenstedt, Elisabeth
Michalík, Andrej
Dupain, Célia
Delcourt, Thomas
Huet, Sarah
Campenhout, Claude van
Cordero, David
Castellano Garcia, José María
Codony Servat, Carles
Krol, Aurélie
Gonzalo Ruíz, Javier
Damme, Nancy van
Delnord, Marie
Carbone, Roberta
Trapani, Valentina
Garsse, Steven A. D. van
Van Den Bulcke, Marc
Keywords: Diagnòstic immunològic
Citometria de fluxe
Immunodiagnosis
Flow cytometry
Issue Date: 19-May-2025
Publisher: Elsevier BV
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, Conformit & eacute; Europ & eacute;enne 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.
Note: Reproducció del document publicat a: https://doi.org/10.1016/j.esmoop.2025.105127
It is part of: ESMO Open, 2025, vol. 10, num. 6
URI: https://hdl.handle.net/2445/222245
Related resource: https://doi.org/10.1016/j.esmoop.2025.105127
ISSN: 2059-7029
Appears in Collections:Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

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