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

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.