CCQM-CAWG Workshop on advancing metrology for extracellular vesicles (EVs) across diagnostics, therapeutics, and regulatory science

Please join us for the first session of our three‑part virtual workshop series exploring the rapidly evolving field of extracellular vesicles (EVs). This Session 1 focuses on the diagnostic potential of EVs and the scientific, technical, and clinical considerations shaping their use as biomarkers.

This session brings together invited speakers with extensive experience in extracellular vesicle (EV) research to provide a comprehensive overview of current approaches for EV characterisation. They will discuss methods for identifying EV subtypes, detecting disease‑specific biomarkers, and navigating the complexities of clinical validation. The speakers will also address persistent challenges around reproducibility and standardisation—key hurdles that continue to limit broader adoption across the field.

We will explore the remaining gaps in EV metrology and outline what is needed to advance measurement science in this rapidly developing area. The workshop will conclude with a panel discussion featuring experts from research, clinical practice, and industry, who will share their perspectives on the technical and clinical barriers that must be overcome to fully realise the potential of EV‑based diagnostics.

Participants will also have the opportunity to engage through an interactive questionnaire designed to capture perspectives, highlight community needs, and guide future sessions in the series.

This is the second session of the CCQM CAWG workshop series that will focus on the therapeutic potential of extracellular vesicles (EVs), with invited speakers who bring extensive expertise in EV‑based gene delivery. The session will outline current methods for improving targeting strategies, optimising EV loading, and reviewing insights from clinical studies exploring EVs as delivery vehicles.

Speakers will also address key considerations for safety, scalability, and manufacturing where robust measurement science is essential. Remaining metrological challenges, including the need for standardised assays and process controls will be highlighted. The session concludes with a panel discussion on biomanufacturing and an interactive questionnaire designed to capture perspectives, highlight community needs, and guide future sessions in the series.

This is the third and final session of our three-part virtual CCQM CAWG workshop series exploring the rapidly evolving field of extracellular vesicles (EV). This session will examine the evolving regulatory landscape for extracellular vesicles (EVs) in both diagnostic and therapeutic applications. Invited experts will outline the current status of EV‑related regulations and guidance from regulatory agencies and discuss how these frameworks intersect with ongoing standardisation efforts, including ISEV and the MISEV guidelines.

The session will also highlight the availability and role of reference materials, along with the metrological considerations needed to support regulatory confidence and harmonisation. The session concludes with an open forum for stakeholder feedback and an interactive questionnaire to capture community perspectives and highlight measurement needs.