Classification and Ontology of Macromolecular Complexes in Liquid Biopsies

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This is a continuing project, started in 2021-2022 in response to ongoing requests from researchers across the biomedical research space to provide input on the design and interpretation of "exosome" studies, pertaining to various diseases. Although the International Society for Extracellular Vesicles, the largest society of EV and "exosome" researchers, defines "exosomes" in terms of how these structures are produced by cells, researchers studying EVs and "exosomes" in liquid biopsies generally have no tools with which to determine whether an extracellular vesicle in a biofluid arose from an intraluminal body and released (via a pathway for exosome biogenesis) or whether an extracellular vesicle was shed from the surface of the cell. Moreover, several additional categories of extracellular macromolecular complexes, such as exomeres and supermeres, have been identified, for which researchers encounter similar challenges of ontologic clarity. The first steps for this project will be to assess the state of the field and delineate potential next steps towards harmonized terminologies. This will be a large collaborative initiative, encompassing the EV biology and Liquid Biopsy/Molecular Diagnostics communities, and will engage with regulatory communities working with "exosome" metrology, diagnostics, and therapeutics.