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Review
. 2025 May:209:104619.
doi: 10.1016/j.critrevonc.2025.104619. Epub 2025 Jan 15.

Role of the International Society of Liquid Biopsy (ISLB) in establishing quality control frameworks for clinical integration

Nicola Fusco  1 , Eloisa Jantus-Lewintre  2 , Maria Jose Serrano  3 , David Gandara  4 , Umberto Malapelle  5 , Christian Rolfo  6
Affiliations
Review

Role of the International Society of Liquid Biopsy (ISLB) in establishing quality control frameworks for clinical integration

Nicola Fusco et al. Crit Rev Oncol Hematol. 2025 May.

Abstract

Liquid biopsy (LB) has revolutionized molecular pathology, offering non-invasive insights into tumor biology. However, its wide adoption is hindered by a lack of standardized protocols, requiring robust quality control frameworks and harmonized diagnostic workflows. Large consensensus initiatives are needed to establish effective standard operating procedures (SOPs), particularly for circulating tumor DNA (ctDNA) testing, tailored to different disease types and stages. The International Society of Liquid Biopsy (ISLB) has addressed these challenges by forming a Quality Control and Accreditation Committee, focused on developing frameworks for pre-analytical, analytical, and interpretive processes. Key priorities include mitigating pre-analytical variability with stringent guidelines for blood handling and ensuring adherence to international standards like ISO 15189 and CLIA/CAP. ISLB emphasizes the need for harmonized methodologiesand diagnostic workflows for molecular testing. Collaboration with global initiatives, including the European Society of Medical Oncology (ESMO), American Society of Clinical Oncology (ASCO), and International Liquid Biopsy Standardization Alliance (ILSA) are vital for integrating LB into clinical care, advancing precision oncology, and improving patient outcomes .

Keywords: Accreditation; Circulating tumor DNA; External quality assessment; Liquid biopsy; Quality control; Quality standards.

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Conflict of interest statement

Declaration of Competing Interest N.F. 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. U.M. from Boehringer Ingelheim, Roche, MSD, Amgen, Thermo-Fisher Scientific, Eli Lilly & Company, Diaceutics, GSK, Merck, AstraZeneca, Janssen, Diatech, Novartis and Hedera. C.R. from AstraZeneca, Roche, MSD, Inivata, Archer, Boston Pharmaceuticals, MD Serono, Novartis, Bayer, Invitae, Regeneron, Janssen, Bostongene, Novocure, Scientific Advisory Board member of Imagene, and institutional research funding from LCRF- Pfizer and NCRF, non-renumerated research support from GuardantHealth and Foundation Medicine. All Authors have non-renumerated roles at the International Society of Liquid Biopsy (ISLB).

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