Classification and Ontology of Macromolecular Complexes in Liquid Biopsies

这是一个新项目，于2021-2022年启动，以回应整个生物医学研究领域的研究人员不断提出的要求，即为设计和解释与各种疾病有关的“外显体”研究提供投入。尽管最大的EV和“外体”研究人员协会--国际细胞外小泡协会--根据细胞如何产生这些结构来定义“外体”，但研究EV和液体活检中的“外体”的研究人员通常没有工具来确定生物流体中的细胞外小泡是从腔内体内产生并释放(通过外体生物发生的途径)，还是细胞外小泡是从细胞表面脱落的。此外，还确定了几种额外的细胞外大分子复合体，如外显子和超聚体，研究人员在本体清晰度方面遇到了类似的挑战。该项目的第一步将是评估实地状况，并为统一术语制定下一步可能采取的步骤。这将是一项大型合作倡议，包括EV生物学和液体活检/分子诊断学社区，并将与从事“外显体”计量、诊断和治疗工作的监管社区接触。

This is a new 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.