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

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.