Diagnostic assays employing neuron-derived exosomes

A method of identifying or capturing neuron-derived EV, comprising:

• a. providing an EV-containing biofluid sample,
• b. contacting the sample with affinity molecules capable of binding to target molecules on the surface of the EV, under conditions enabling specific binding of the affinity molecules to their corresponding target molecules, wherein the target molecules comprise NLGN3 and GAP43, and
• c. identifying or capturing the EV bound to the affinity molecules.

A system for isolating neuron-derived extracellular vesicles (EV), comprising means for identifying or capturing neuron-derived EV from a biofluid sample, comprising substance-bound affinity molecules capable of binding to target molecules on the surface of the EV, and further comprising (i) means for determining the accuracy of the system, and/or (ii) means for determining the levels of at least one biomarker in the captured EV,

• wherein at least one of the target molecules is a synaptic protein selected from the group consisting of NLGN3 and GAP43,
• wherein the means for determining the accuracy of the system comprise particles that display the at least one synaptic protein and are labeled by a marker, and
• wherein the at least one biomarker is selected from the group consisting of Tau, phosphorylated Tau (p-Tau), Amyloid-beta 42 (Aβ42), NLGN, TDP43, clusterin, SYP, BIM, NEFL, ENO2, NRGN, and GPR26 gene products, and combinations thereof, or selected from the group consisting of LC3, Cathepsin D, NRF2, Aβ42, p-Tau, PSD95, proBDNF, COX2, EIF2C2 and NF-κB and combinations thereof.

A kit for identifying or capturing neuron-derived extracellular vesicles (EV), comprising NLGN3-specific affinity molecules and GAP43-specific affinity molecules, capable of binding to NLGN3 and GAP43, respectively, on the surface of EV, and means for identifying or capturing the EV bound to the affinity molecules.