Fusco Nicola, Venetis Konstantinos, Pepe Francesco, Shetty Omshree, Farinas Silvia Calabuig, Heeke Simon, Burnier Julia V, Patton Simon J, Heitzer Ellen, Nigita Giovanni, Hofman Paul, Serrano Maria Jose, Cristofanilli Massimo, Jantus-Lewintre Eloisa, Gandara David R, Rolfo Christian, Malapelle Umberto
Division of Pathology, European Institute of Oncology IRCCS, Milan, Italy.
Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.
J Liq Biopsy. 2025 May 24;8:100301. doi: 10.1016/j.jlb.2025.100301. eCollection 2025 Jun.
Circulating tumor DNA (ctDNA) testing has transformed precision oncology by enabling the non-invasive detection of actionable mutations. To facilitate broader clinical adoption and improve testing accuracy, standardized quality criteria must be clearly defined and universally implemented. The International Society of Liquid Biopsy (ISLB) established the Quality Control and Accreditation Committee to develop consensus-based minimal standards for ctDNA analysis in oncology. Ensuring reliable and reproducible ctDNA testing necessitates standardization across the pre-analytical, analytical, and post-analytical phases. Key considerations include appropriate blood collection, efficient cfDNA isolation and purification, thorough assay validation, and precise data interpretation. The ISLB is committed to leading collaborative efforts among laboratories, regulatory bodies, and professional organizations to advance standardization and ensure high-quality ctDNA testing worldwide. Through initiatives led by the Quality Control and Accreditation Committee, educational programs, and multidisciplinary stakeholder workshops, ISLB provides a structured framework to promote standardization and foster innovation. By addressing current challenges and advocating for robust quality standards, ctDNA testing can reach its full potential in advancing personalized cancer care, enabling more precise and timely interventions for patients. This manuscript provides the first global initiative for quality control in liquid biopsy, presenting the ISLB perspective on minimal requirements for ctDNA testing in solid tumors.
循环肿瘤DNA（ctDNA）检测通过实现可操作突变的无创检测，改变了精准肿瘤学。为促进更广泛的临床应用并提高检测准确性，必须明确界定并普遍实施标准化质量标准。国际液体活检协会（ISLB）成立了质量控制与认证委员会，以制定基于共识的肿瘤学ctDNA分析最低标准。确保可靠且可重复的ctDNA检测需要在分析前阶段、分析阶段和分析后阶段进行标准化。关键考虑因素包括适当的血液采集、高效的cfDNA分离和纯化、全面的检测验证以及精确的数据解读。ISLB致力于引领实验室、监管机构和专业组织之间的合作努力，以推进标准化并确保全球范围内高质量的ctDNA检测。通过质量控制与认证委员会牵头的举措、教育项目以及多学科利益相关者研讨会，ISLB提供了一个结构化框架，以促进标准化并推动创新。通过应对当前挑战并倡导强有力的质量标准，ctDNA检测能够在推进个性化癌症治疗方面充分发挥其潜力，为患者实现更精准、及时的干预。本手稿提供了液体活检质量控制的首个全球倡议，呈现了ISLB对实体瘤ctDNA检测最低要求的观点。
