通过OncNGS商业化前采购（PCP）计划开发和实施新型液体活检NGS面板

IF 7.1 2区医学 Q1 ONCOLOGY

ESMO Open Pub Date : 2025-05-19 DOI:10.1016/j.esmoop.2025.105127

G. Raicevic Toungouz , R. Alessandrello , P. Giacomini , M. Kamal , M. Gausachs , L. Mazzarella , P. Sujobert , G. Frigè , A. Alay , J.M. Planchon , O. Blau , M.R. Mias Carballal , H. Antoine-Poirel , E. Nadal , L. Bullinger , A. Hebrant , N. Servant , N. D’Haene , P. Aftimos , E. Silkenstedt , M. Van Den Bulcke

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引用次数: 0

摘要

循环肿瘤DNA （ctDNA）分析正在改变肿瘤学，但诸如分析灵敏度不足、难以解释变异、次优周转时间、有限的部署灵活性和高成本等挑战阻碍了其广泛采用，并引起了对整个欧洲卫生保健系统的可持续性报销的担忧。为了应对这些挑战，我们创建了OncNGS联盟，由学术、公立和私立医院（买家团体）和几个支持实体组成，以开展欧洲商业前采购（PCP）计划。该财团确定了ctDNA诊断测试的要求，进行了公开的市场咨询，并发起了招标。供应商被邀请开发端到端符合conformit europ体外诊断（CE-IVD）标准的解决方案，将湿实验室、干实验室和报告工作流程集成到一个程序中，提供较短的周转时间和合理的成本。OncNGS联盟定义了一种通用的、模块化的、具有成本效益的解决方案的标准，可集中部署或现场部署，并适应精确肿瘤学的进步。招标于2022年7月启动，吸引了七家公司，其中四家被选中进行第一阶段的oncngs解决方案设计。从这些，三个进入第二阶段的原型。最终，两家承包商获得了第三阶段的合同，以评估其原型的临床性能。通过利用PCP方法，OncNGS旨在提供创新的、负担得起的解决方案，以标准化欧盟国家的ctDNA检测和报告，改善肿瘤患者的诊断和治疗策略。

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

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.

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来源期刊

ESMO Open Medicine-Oncology

CiteScore

11.70

自引率

2.70%

发文量

255

审稿时长

10 weeks

期刊介绍： ESMO Open is the online-only, open access journal of the European Society for Medical Oncology (ESMO). It is a peer-reviewed publication dedicated to sharing high-quality medical research and educational materials from various fields of oncology. The journal specifically focuses on showcasing innovative clinical and translational cancer research. ESMO Open aims to publish a wide range of research articles covering all aspects of oncology, including experimental studies, translational research, diagnostic advancements, and therapeutic approaches. The content of the journal includes original research articles, insightful reviews, thought-provoking editorials, and correspondence. Moreover, the journal warmly welcomes the submission of phase I trials and meta-analyses. It also showcases reviews from significant ESMO conferences and meetings, as well as publishes important position statements on behalf of ESMO. Overall, ESMO Open offers a platform for scientists, clinicians, and researchers in the field of oncology to share their valuable insights and contribute to advancing the understanding and treatment of cancer. The journal serves as a source of up-to-date information and fosters collaboration within the oncology community.