EV-based biomarkers: Commercialisation and Clinical Implementation

The ISEV workshop “Extracellular Vesicle (EV)-based biomarkers” aims to discuss key challenges in commercialisation and clinical implementation of EV-based biomarkers. The biomarker potential of EVs, and their application as liquid biopsies, was first demonstrated over two decades ago. Whilst considerable interest in using EVs as biomarkers for a wide range of diseases exists, progress in the field is hindered by a lack of development of EV-based biomarkers under formal regulatory requirements. For example, The Therapeutic Goods Administration (TGA, like the FDA in the USA) in Australia clearly defines the pathway for the clinical implementation of all new diagnostic tests and the clinical evidence appropriate for its intended use and risk classification (Therapeutic Goods (Medical Devices) Regulations 2002). Specific requirements that must be satisfied to ensure a feasible pathway for clinical implementation and compliance with the conformity assessment procedure of the Medical Devices Regulations include evidencing, analytical performance, clinical performance, and clinical utility. Thus, this workshop aims to provide a platform to discuss challenges of the EV community in translating EV-based biomarkers into clinical practice, with focus on the regulatory requirements and commercial aspects.

The deadline to apply was Friday 28 July 2023, 11:59pm CET. Approximately 50 participants will be selected to attend the workshop and will be notified by 15 August 2023. Please note that applications with abstracts/data/proposed presentations will be prioritized. If accepted, there is no charge to attend.

The in-person workshop will be held in Aalborg (Denmark) from 12 to 14 October 2023. Preliminary program details can be found at this link.

Short talks and roundtable discussions will revolve around five main topics:

- Topic 1: Clinical need, commercial viability, and feasibility for EV biomarkers

- Topic 2: Discovery of candidate EV biomarker(s)

- Topic 3: Biomarker verification and scientific validation

- Topic 4: EV biomarker prototype development and testing

- Topic 5: EV biomarker implementation, regulatory considerations, and business models


Click here to view the program


International Organizing Committee:

Carlos Salomon (co-chair) – The University of Queensland, Australia

Aase Handberg (co-chair) – Aalborg University, Denmark

Metka Lenassi - University in Ljubljana, Slovenia

Andreas Möller - The Chinese University of Hong Kong

Saumya Das – Harvard University, USA

Malene M Jørgensen - Aalborg University, Denmark

Raghu Kalluri - MD Anderson Cancer Center, USA

Lorraine O'Driscoll - Trinity College Dublin, Ireland