Frequently Asked
Questions
How do we know NDE are specific?
By a combination of multiple surrogate evidence. We can detect significant elevation in neuron-specific proteins Tau, BDNF, SYP, RGMa, NLGN, GRIN2a, and others over IgG control and EV-depleted samples. Similar evidence is also demonstrated using neuron-specific mRNA, such as NRGN and EBO2. In addition, enrichment was demonstrated by unbiased analysis of proteomic analysis as well as mRNA and miRNA sequencing.
What types of neurons release NDE?
NDEs come from multiple cell types and brain regions. We have demonstrated RNA and protein markers of glutaminergic, dopaminergic and GABAargic neurons. It is reasonable to assume that other neurons also contribute. We have not yet identified selection antibodies for specific neuronal subtypes. It is important to emphasize that there is a tradeoff between enrichment level (specificity) and EV-yield (sensitivity), and it is not clear if neuronal subtype enrichment will be a helpful process.
Do NDE come only from CNS but also from PNS?
Any cell that releases EVs that contain the isolation markers GAP43, NLGN, or others is expected to be captured. CNS and PNS neurons are almost identical in their protein composition, so we expect that NDEs originate from both CNS and PNS. We would like to emphasize that in two studies, we have detected correlation between brain cells and plasma NDEs, and thus know it represents CNS neurons.
Can we do glia-derived exosomes as well?
We have identified markers for oligodendrocyte-derived EVs and verified enrichment using PCR, ELISA, and RNAseq. We have used GLAST1, which was reported in the literature for astrocyte-derived EVs, but have yet to validate the level of enrichment. Microglia are almost identical to macrophages; hence, we can enrich for myeloid cells, but not specifically for microglia.
Are the assays validated?
The assay is not fully validated yet (expected Q2 2026). However, the assay is automated and passed many pre-validation testing, thus deeming it qualified for clinical testing.
Can you operate under GLP? Can you operate under CLIA?
NeuroDex works with clear SOPs and uses GLP-compliant instruments. Several companies have audited NeuroDex's quality management system and are progressing into clinical trials. We are now working on the FAD audited level.
What makes your extracellular vesicle isolation better than other types of isolation?
NeuroDex is the only company that has a specific isolation of a subpopulation of plasma EVs that corresponds to neurons. NeuroDex has also automated the enrichment process and has the ability to perform EV isolation in a 96-well plate format with low within and between batch variability.
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