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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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