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Development and implementation of novel liquid biopsy NGS panels via the OncNGS precommercial procurement (PCP) initiative

Health and disease monitoring  
Quality of healthcare  
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Public Access

Published

Peer reviewed scientific article

English

DOI : https://doi.org/10.1016/j.esmoop.2025.105127 [2]

Authors

Gordana Raicevic [3]; R. Alessandrello [4]; P. Giacomini [5]; M. Kamal [6]; M. Gausachs [7]; L. Mazzarella [8]; P. Sujobert [9]; G. Frigè [10]; A. Alay [11]; J.M. Planchon [12]; O. Blau [13]; M.R. Mias Carballal [14]; H Antoine-Poirel [15]; E. Nadal [16]; L. Bullinger [17]; Aline Hébrant [18]; N. Servant [19]; N. D’Haene [20]; P. Aftimos [21]; E. Silkenstedt [22]; A. Michalík [23]; C. Dupain [24]; T. Delcourt [25]; S. Huet [26]; C. Van Campenhout [27]; Cordero, D. [28]; Garcia J.M. Castellano [29]; C. Codony [30]; A. Krol [31]; J. Gonzalo [32]; N. Van Damme [33]; Marie Delnord [34]; R. Carbone [35]; V. Trapani [36]; S. Van Garsse [37]; M Van Den Bulcke [38]

Keywords

  1. comprehensive genomic profiling (CGP) [39]
  2. ctDNA [40]
  3. liquid biopsy [41]
  4. OncNGS [42]
  5. precommercial procurement (PCP) [43]
Article written during project(s) : 
oncNGS oncNGS [44]

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 procure…
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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.

Associated health topics:

Cancer [45]
Quality of healthcare [46]

Source URL:https://sciensano.be/en/biblio/development-and-implementation-novel-liquid-biopsy-ngs-panels-oncngs-precommercial-procurement-pcp

Links
[1] https://sciensano.be/sites/default/files/doc104_oncngs_pcp_raicevic_et_al_2025_en.pdf [2] https://doi.org/10.1016/j.esmoop.2025.105127 [3] https://sciensano.be/en/people/gordana-raicevic-toungouz/biblio [4] https://sciensano.be/en/biblio?f%5Bauthor%5D=191619&f%5Bsearch%5D=R.%20Alessandrello [5] https://sciensano.be/en/biblio?f%5Bauthor%5D=191620&f%5Bsearch%5D=P.%20Giacomini [6] https://sciensano.be/en/biblio?f%5Bauthor%5D=191621&f%5Bsearch%5D=M.%20Kamal [7] https://sciensano.be/en/biblio?f%5Bauthor%5D=191622&f%5Bsearch%5D=M.%20Gausachs [8] https://sciensano.be/en/biblio?f%5Bauthor%5D=191623&f%5Bsearch%5D=L.%20Mazzarella [9] https://sciensano.be/en/biblio?f%5Bauthor%5D=191624&f%5Bsearch%5D=P.%20Sujobert [10] https://sciensano.be/en/biblio?f%5Bauthor%5D=191625&f%5Bsearch%5D=G.%20Frig%C3%A8 [11] https://sciensano.be/en/biblio?f%5Bauthor%5D=191626&f%5Bsearch%5D=A.%20Alay [12] https://sciensano.be/en/biblio?f%5Bauthor%5D=191627&f%5Bsearch%5D=J.M.%20Planchon [13] https://sciensano.be/en/biblio?f%5Bauthor%5D=191628&f%5Bsearch%5D=O.%20Blau [14] https://sciensano.be/en/biblio?f%5Bauthor%5D=191629&f%5Bsearch%5D=M.R.%20Mias%20Carballal [15] https://sciensano.be/en/people/helene-antoine-poirel/biblio [16] https://sciensano.be/en/biblio?f%5Bauthor%5D=191631&f%5Bsearch%5D=E.%20Nadal [17] https://sciensano.be/en/biblio?f%5Bauthor%5D=191632&f%5Bsearch%5D=L.%20Bullinger [18] https://sciensano.be/en/people/aline-hebrant/biblio [19] https://sciensano.be/en/biblio?f%5Bauthor%5D=191634&f%5Bsearch%5D=N.%20Servant [20] https://sciensano.be/en/biblio?f%5Bauthor%5D=191635&f%5Bsearch%5D=N.%20D%E2%80%99Haene [21] https://sciensano.be/en/biblio?f%5Bauthor%5D=191636&f%5Bsearch%5D=P.%20Aftimos [22] https://sciensano.be/en/biblio?f%5Bauthor%5D=191637&f%5Bsearch%5D=E.%20Silkenstedt [23] https://sciensano.be/en/biblio?f%5Bauthor%5D=191638&f%5Bsearch%5D=A.%20Michal%C3%ADk [24] https://sciensano.be/en/biblio?f%5Bauthor%5D=191639&f%5Bsearch%5D=C.%20Dupain [25] https://sciensano.be/en/biblio?f%5Bauthor%5D=191640&f%5Bsearch%5D=T.%20Delcourt [26] https://sciensano.be/en/biblio?f%5Bauthor%5D=191641&f%5Bsearch%5D=S.%20Huet [27] https://sciensano.be/en/biblio?f%5Bauthor%5D=191642&f%5Bsearch%5D=C.%20Van%20Campenhout [28] https://sciensano.be/en/biblio?f%5Bauthor%5D=191643&f%5Bsearch%5D=Cordero%2C%20D. [29] https://sciensano.be/en/biblio?f%5Bauthor%5D=191644&f%5Bsearch%5D=Garcia%20J.M.%20Castellano [30] https://sciensano.be/en/biblio?f%5Bauthor%5D=191645&f%5Bsearch%5D=C.%20Codony [31] https://sciensano.be/en/biblio?f%5Bauthor%5D=191646&f%5Bsearch%5D=A.%20Krol [32] https://sciensano.be/en/biblio?f%5Bauthor%5D=191647&f%5Bsearch%5D=J.%20Gonzalo [33] https://sciensano.be/en/biblio?f%5Bauthor%5D=191648&f%5Bsearch%5D=N.%20Van%20Damme [34] https://sciensano.be/en/people/marie-delnord/biblio [35] https://sciensano.be/en/biblio?f%5Bauthor%5D=191650&f%5Bsearch%5D=R.%20Carbone [36] https://sciensano.be/en/biblio?f%5Bauthor%5D=191651&f%5Bsearch%5D=V.%20Trapani [37] https://sciensano.be/en/biblio?f%5Bauthor%5D=191652&f%5Bsearch%5D=S.%20Van%20Garsse [38] https://sciensano.be/en/biblio?f%5Bauthor%5D=191657&f%5Bsearch%5D=M%20Van%20Den%20Bulcke [39] https://sciensano.be/en/biblio?f%5Bkeyword%5D=38878&f%5Bsearch%5D=comprehensive%20genomic%20profiling%20%28CGP%29 [40] https://sciensano.be/en/biblio?f%5Bkeyword%5D=38876&f%5Bsearch%5D=ctDNA [41] https://sciensano.be/en/biblio?f%5Bkeyword%5D=38875&f%5Bsearch%5D=liquid%20biopsy [42] https://sciensano.be/en/biblio?f%5Bkeyword%5D=38877&f%5Bsearch%5D=OncNGS [43] https://sciensano.be/en/biblio?f%5Bkeyword%5D=38879&f%5Bsearch%5D=precommercial%20procurement%20%28PCP%29 [44] https://sciensano.be/en/projects/oncngs [45] https://sciensano.be/en/health-topics/cancer [46] https://sciensano.be/en/health-topics/quality-healthcare