Extracellular vesicles are an abundant resource for new biomarkers across all fields of medicine – from oncology to cardiovascular, metabolic, neurologic, infectious and autoimmune disease. Circulating EVs in the blood carry valuable information about the physiological or pathological state of their tissue of origin, their release mechanisms, metabolism and clearance. The size, characteristics, surface markers and cargo have been investigated as promising biomarkers candidates [1–3]. However, despite this potential, substantial challenges still hinder the translation of EV-based biomarker diagnostics into clinical applications for patients:
- Clear definition of pathologically relevant EV populations
- Standardization of sensitive and specific EV isolation and characterization methods
- Development of robust, reproducible, automatable, and cost-effective assays
- Reliable control of biological variability
- Identification and mitigation of pre-analytical influencing factors
- Assurance of accurate analytical assay performance
- Meaningful post-analytical interpretation of results
- Demonstration of clinically relevant applications
- Establishment of diagnostic thresholds
- Validation in large, well-characterized patient and control cohorts
Addressing all of these aspects is essential to meet in vitro diagnostic device regulations and to “move EVs from bench to bedside”.
The German Society for Extracellular Vesicles (GSEV) brings together numerous experts of EV research and is closely linked to national and international networks [4]. As early as 2018, GSEV representatives established contact with the International Society of Oncology and Biomarkers (ISOBM) and organized a well-received EV session at the 45th ISOBM Conference in Hamburg.
The ISOBM was founded in the early 1970s, at a time when the first tumor-associated antigens were being discovered and the first immunoassays developed. Each year, basic researchers, scientists, laboratory physicians, and clinicians from all around the world met to share their findings and collaborate in rigorously addressing every step required to translate these diagnostics into clinical practice.
Among the Society’s key achievements were the discovery of new biomarkers, production of specific antibodies, optimization of tumor marker assay technologies, establishment of liquid biobanks, standardization of clinical biomarker trials, and development of practice guidelines. Over the past two decades, ISOBM has expanded its scope to include omics technologies, advanced biostatistics, and emerging biomarker classes such as circulating nucleic acids, epigenetics, circulating tumor cells, EVs, and radiomics – always with the goal of identifying and validating diagnostic tools that complement or surpass existing methods, thereby improving cancer patient care [5, 6]
The meeting of GSEV and ISOBM has been a fortunate coincidence for both societies, uniting renowned expertise in EVs with long-standing experience in biomarker assay development and validation. At this year’s 47th ISOBM Conference in Murnau, Germany (October 13 - 16), GSEV will take an active role by organizing a dedicated EV session and an EV workshop for more in-depth discussions. This will be a valuable opportunity for scientists from both fields to meet, exchange knowledge, and learn from one another [7]. We hope that this partnership will continue to grow in the coming years, helping to unlock the immense potential of EVs for cancer diagnostics.
