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Review
. 2025 May 24:8:100301.
doi: 10.1016/j.jlb.2025.100301. eCollection 2025 Jun.

International society of liquid biopsy (ISLB) perspective on minimal requirements for ctDNA testing in solid tumors

Nicola Fusco  1   2 , Konstantinos Venetis  1 , Francesco Pepe  3 , Omshree Shetty  4 , Silvia Calabuig Farinas  5   6   7   8 , Simon Heeke  9 , Julia V Burnier  10 , Simon J Patton  11 , Ellen Heitzer  12 , Giovanni Nigita  13   14 , Paul Hofman  15 , Maria Jose Serrano  16   17   18 , Massimo Cristofanilli  19 , Eloisa Jantus-Lewintre  20 , David R Gandara  21 , Christian Rolfo  22 , Umberto Malapelle  3
Affiliations
Review

International society of liquid biopsy (ISLB) perspective on minimal requirements for ctDNA testing in solid tumors

Nicola Fusco et al. J Liq Biopsy. .

Abstract

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.

Keywords: Circulating tumor DNA (ctDNA); Liquid biopsy; Precision oncology; Quality assurance; Standardization.

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Conflict of interest statement

Nicola Fusco: Has received honoraria for consulting, advisory roles, speakers' bureau participation, travel, and/or research grants from Merck Sharp & Dohme (MSD), Merck, Novartis, AstraZeneca, Roche, Menarini Group, Daiichi Sankyo, GlaxoSmithKline (GSK), Gilead, Sysmex, Veracyte Inc., Sakura, Leica Biosystems, Thermo-Fisher Scientific, Lilly, Pfizer, Abbvie. Konstantinos Venetis: Has received honoraria for speaker bureau from Merck Sharp & Dohme (MSD), Roche, AstraZeneca, and Johnson & Johnson. Francesco Pepe: Has received personal fees (as speaker bureau or advisor) from Menarini and Roche. Simon Heeke: Has received speaker fees from Guardant health and AstraZeneca and reports intellectual property on the classification of lung cancer. Simon Patton: has received financial support from AstraZeneca, MSD, and Johnson & Johnson for EMQN CIC to deliver external quality assessment activities to laboratories worldwide, has received honoraria from AstraZeneca for delivering webinar series, and has received travel costs from AstraZeneca to support delivery of a lecture at a major European conference. Ellen Heitzer: Has received unrelated funding from Illumina, Roche, Servier, Freenome, and PreAnalytiX, and received honoraria from Roche and Astra Zeneca for advisory boards unrelated to our study. Paul Hoffman: has received honoraria for travel support and consulting/advisory roles for AstraZeneca, Roche, Bristol-Myers Squibb, Biocartis, Bayer, Ed Lilly, Diaceutics, Novartis, Pfizer, MSD, Qiagen, Thermo-Fisher Scientist, Janssen, Amgen, Abbvie, Biocartis, Pierre Fabre, and Sanofi, outside the submitted work. Massimo Cristofanilli: reports personal fees from Lilly, Sermonix, Data Genomics, Foundation Medicine, Guardant Health, Celcuity, Iylon, and Ellipses and grants and personal fees from Pfizer, AZ and Menarini, all outside the submitted work. David R. Gandara: Honoraria: Merck Consulting or Advisory Role: AstraZeneca (Inst), Guardant Health (Inst), OncoCyte (Inst), IO Biotech (Inst), Roche/Genentech (Inst), Adagene (Inst), Guardant Health (Inst), OncoHost (Inst) Research Funding: Merck (Inst), Amgen (Inst), Genentech (Inst), AstraZeneca (Inst), Astex Pharmaceuticals (Inst). Christian Rolfo: speaker honoraria: AstraZeneca, Roche and MSD; advisory board honoraria: Inivata, Archer, Boston Pharmaceuticals, EMD Serono, Inc., Rockland, MA, USA, an affiliate of Merck KGaA, Novartis, Bayer, Invitae, Regeneron, Janssen, Bostongene, Novocure; scientific advisory board member: Imagene; institutional research funding: LCRF- Pfizer and NCRF; non-renumerated research support: Guardant Health and Foundation Medicine; non-renumerated leadership roles: the International Society of Liquid Biopsy (ISLB), the International Association for Study of Lung Cancer (IASLC), and the European School of Oncology (ESO). Umberto Malapelle: Has received personal fees (as consultant and/or speaker bureau) from Boehringer Ingelheim, Roche, MSD, Amgen, Thermo Fisher Scientific, Eli Lilly, Diaceutics, GSK, Merck and AstraZeneca, Janssen, Diatech, Novartis and Hedera, all unrelated to the current work. No other potential conflicts of interest are reported.

Figures

Fig. 1
Fig. 1
Workflow of liquid biopsy pre-analytical steps and recommendations for circulating tumor DNA (ctDNA) analysis. MRD, Minimal residual disease; RT, Room temperature; cfDNA, Circulating-free DNA.
See this image and copyright information in PMC

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