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, widespread adoption is hindered by a lack of standardized protocols, requiring robust quality control and harmonized workflows. Large-scale studies are needed to establish effective standard operating procedures (SOPs), particularly for circulating tumor DNA (ctDNA) assays tailored to different disease 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 harmonized methodologies, with advanced techniques like droplet digital PCR and next-generation sequencing requiring unified workflows. 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), supports the validation of ctDNA testing. These efforts are vital for integrating LB into clinical care, advancing precision oncology, and improving patient outcomes through reliable and standardized applications.