Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Jun;10(6):105127.
doi: 10.1016/j.esmoop.2025.105127. Epub 2025 May 19.

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

G Raicevic Toungouz  1 , R Alessandrello  2 , P Giacomini  3 , M Kamal  4 , M Gausachs  5 , L Mazzarella  6 , P Sujobert  7 , G Frigè  6 , A Alay  5 , J M Planchon  8 , O Blau  9 , M R Mias Carballal  2 , H Antoine-Poirel  10 , E Nadal  5 , L Bullinger  9 , A Hebrant  10 , N Servant  11 , N D'Haene  12 , P Aftimos  12 , E Silkenstedt  13 , A Michalík  14 , C Dupain  15 , T Delcourt  10 , S Huet  7 , C Van Campenhout  12 , D Cordero  5 , J M Castellano Garcia  2 , C Codony  5 , A Krol  16 , J Gonzalo  17 , N Van Damme  18 , M Delnord  10 , R Carbone  6 , V Trapani  19 , S Van Garsse  20 , M Van Den Bulcke  10
Affiliations

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

G Raicevic Toungouz et al. ESMO Open. 2025 Jun.

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.

Keywords: OncNGS; comprehensive genomic profiling (CGP); ctDNA; liquid biopsy; precommercial procurement (PCP).

PubMed Disclaimer

Figures

Figure 1
Figure 1
Overview of the OncNGS PCP procedure and project timeline. CE-IVD, Conformité Européenne In Vitro Diagnostic; CfT, call for tender; GDPR, General Data Protection Regulation; IP-FTO, intellectual property freedom to operate; OMC, open market consultation; PCP, precommercial procurement; PIN, prior notice information.
See this image and copyright information in PMC

References

    1. Pankiw M., Brezden-Masley C., Charames G.S. Comprehensive genomic profiling for oncological advancements by precision medicine. Med Oncol. 2023;41:1. - PubMed
    1. Lone S.N., Nisar S., Masoodi T., et al. Liquid biopsy: a step closer to transform diagnosis, prognosis and future of cancer treatments. Mol Cancer. 2022;21:79. - PMC - PubMed
    1. Boukovala M., Westphalen B.C., Probst V. Liquid biopsy into the clinics: current evidence and future perspectives. J Liq Biopsy. 2024;4 - PMC - PubMed
    1. de Jager V.D., Giacomini P., Fairley J.A., et al. ELBS ctDNA Workshop Group Reporting of molecular test results from cell-free DNA analyses: expert consensus recommendations from the 2023 European Liquid Biopsy Society ctDNA Workshop. EBioMedicine. 2025;114 - PMC - PubMed
    1. Alessandrello R., Arrizabalaga Garde I., Meis Piñeiro U., Alonso Elizondo Cordero O., Sanchis-Amat M., Maspons R. Teoria del canvi, resultats neutrals respecte al tipus de necessitats no satisfetes en l’àmbit de la salut i permeabilitat de les compres públiques d’innovació al valor. Ann Med. 2021;104:164–167.

Substances