<?xml version="1.0" encoding="UTF-8"?><xml><records><record><source-app name="Biblio" version="7.x">Drupal-Biblio</source-app><ref-type>17</ref-type><contributors><authors><author><style face="normal" font="default" size="100%">Gordana Raicevic</style></author><author><style face="normal" font="default" size="100%">R. Alessandrello</style></author><author><style face="normal" font="default" size="100%">P. Giacomini</style></author><author><style face="normal" font="default" size="100%">M. Kamal</style></author><author><style face="normal" font="default" size="100%">M. Gausachs</style></author><author><style face="normal" font="default" size="100%">L. Mazzarella</style></author><author><style face="normal" font="default" size="100%">P. Sujobert</style></author><author><style face="normal" font="default" size="100%">G. Frigè</style></author><author><style face="normal" font="default" size="100%">A. Alay</style></author><author><style face="normal" font="default" size="100%">J.M. Planchon</style></author><author><style face="normal" font="default" size="100%">O. Blau</style></author><author><style face="normal" font="default" size="100%">M.R. Mias Carballal</style></author><author><style face="normal" font="default" size="100%">H Antoine-Poirel</style></author><author><style face="normal" font="default" size="100%">E. Nadal</style></author><author><style face="normal" font="default" size="100%">L. Bullinger</style></author><author><style face="normal" font="default" size="100%">Aline Hébrant</style></author><author><style face="normal" font="default" size="100%">N. Servant</style></author><author><style face="normal" font="default" size="100%">N. D’Haene</style></author><author><style face="normal" font="default" size="100%">P. Aftimos</style></author><author><style face="normal" font="default" size="100%">E. Silkenstedt</style></author><author><style face="normal" font="default" size="100%">A. Michalík</style></author><author><style face="normal" font="default" size="100%">C. Dupain</style></author><author><style face="normal" font="default" size="100%">T. Delcourt</style></author><author><style face="normal" font="default" size="100%">S. Huet</style></author><author><style face="normal" font="default" size="100%">C. Van Campenhout</style></author><author><style face="normal" font="default" size="100%">Cordero, D.</style></author><author><style face="normal" font="default" size="100%">Garcia J.M. Castellano</style></author><author><style face="normal" font="default" size="100%">C. Codony</style></author><author><style face="normal" font="default" size="100%">A. Krol</style></author><author><style face="normal" font="default" size="100%">J. Gonzalo</style></author><author><style face="normal" font="default" size="100%">N. Van Damme</style></author><author><style face="normal" font="default" size="100%">Marie Delnord</style></author><author><style face="normal" font="default" size="100%">R. Carbone</style></author><author><style face="normal" font="default" size="100%">V. Trapani</style></author><author><style face="normal" font="default" size="100%">S. Van Garsse</style></author><author><style face="normal" font="default" size="100%">M Van Den Bulcke</style></author></authors></contributors><titles><title><style face="normal" font="default" size="100%">Development and implementation of novel liquid biopsy NGS panels via the OncNGS precommercial procurement (PCP) initiative</style></title><secondary-title><style face="normal" font="default" size="100%">ESMO Open</style></secondary-title></titles><keywords><keyword><style  face="normal" font="default" size="100%">comprehensive genomic profiling (CGP)</style></keyword><keyword><style  face="normal" font="default" size="100%">ctDNA</style></keyword><keyword><style  face="normal" font="default" size="100%">liquid biopsy</style></keyword><keyword><style  face="normal" font="default" size="100%">OncNGS</style></keyword><keyword><style  face="normal" font="default" size="100%">precommercial procurement (PCP)</style></keyword></keywords><dates><year><style  face="normal" font="default" size="100%">2025</style></year><pub-dates><date><style  face="normal" font="default" size="100%">Jan-06-2025</style></date></pub-dates></dates><volume><style face="normal" font="default" size="100%">10</style></volume><language><style face="normal" font="default" size="100%">eng</style></language><abstract><style face="normal" font="default" size="100%">&lt;p&gt;Background&lt;/p&gt;

&lt;p&gt;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.&lt;/p&gt;

&lt;p&gt;Materials and methods&lt;/p&gt;

&lt;p&gt;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&amp;nbsp;In Vitro&amp;nbsp;Diagnostic (CE-IVD)-compliant solution integrating wet laboratory, dry laboratory, and reporting workflow in a single procedure, offering short turnaround time and reasonable cost.&lt;/p&gt;

&lt;p&gt;Results&lt;/p&gt;

&lt;p&gt;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.&lt;/p&gt;

&lt;p&gt;Conclusions&lt;/p&gt;

&lt;p&gt;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.&lt;/p&gt;
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