Several companies and research groups are actively developing extracellular vesicle–based (exosomal or ectosomal) tau and amyloid assays, with efforts spanning academic prototypes to commercial platforms and LDT-oriented workflows. Notable developers include NanoSomiX, NeuroDex, Aethlon/Exosome Sciences, and corporate/academic teams working on exosome-bound Aβ detection methods; conventional plasma p-tau/Aβ providers like Quanterix are not EV-specific but are often used as comparators in this space.[1][2][3][4][5][6]

Commercial and startup developers

  • NanoSomiX (Irvine, CA): Portfolio of brain-derived exosome (BDE) assays with IP covering quantification of exosome subpopulations (including neural lineage markers) and ELISA-format tests; company communications note development history including a blood-based p-tau assay foundation and multiple studies using neuron- and astrocyte-derived exosomes, positioning for neurodegenerative and neurotrauma monitoring.[6]
  • NeuroDex (Natick, MA): ExoSORT platform for neuron-derived exosome isolation and analysis; ADDF Diagnostics Accelerator–funded clinical validation to measure TDP-43/α-synuclein in AD cohorts, building an exosome-of-origin diagnostic menu (with clear applicability to tau/Aβ panels as part of broader neurodegeneration testing).[2]
  • Aethlon Medical / Exosome Sciences: Pioneered “TauSome” (plasma exosomal tau) concept in CTE; ongoing materials describe plasma exosomal tau as a candidate blood biomarker for detecting and monitoring neurodegeneration, establishing EV-tau assay feasibility that is frequently cited in the field.[7][3][8]

Corporate/academic assay technologies for exosomal Aβ/tau

  • Exosome-bound Aβ detection and subtyping: Academic–industry work has shown that subtyping of circulating exosome-bound Aβ reflects brain Aβ pathology, with method details published for binding and detection probes; these studies underpin potential diagnostic workflows for EV-Aβ quantitation and phenotype classification in blood.[5]
  • Aβ-binding exosome detection (Toppan/academic collaborators): Reported a technique to detect individual Aβ1–binding exosomes in blood as risk biomarkers for AD, indicating industrial method development toward EV-Aβ detection at single-vesicle resolution.[4]
  • Immuno-digital invasive cleavage assay (idICA) for EVs: Demonstrated an EV-focused digital assay framework for quantitative detection of extracellular vesicles as accessible biomarkers for preclinical AD, offering a platform that can be applied to EV Aβ/tau targets.[9]
  • iMEP (immunomagnetic exosomal PCR) platform: Sensitive multiplex detection of blood biomarkers via DNA-conjugated antibody capture on exosomes, including rapid detection of Aβ species; points to translational routes for EV-Aβ/tau multi-marker blood tests.[10]

Context from foundational EV–tau/Aβ research

  • Exosomal tau: Multiple studies show that AD synapses and tauopathy models release exosomal tau (often C-terminal–truncated and oligomeric) with seeding activity, supporting the rationale for EV-tau assays as pathophysiologically relevant biomarkers.[11][12][13]
  • Exosomal Aβ: Work has shown Aβ peptides are released associated with exosomes and that exosome composition could promote amyloidogenesis, providing a mechanistic basis for measuring exosome-bound Aβ in blood.[14][15][16]

Non–EV-specific but relevant benchmarks

  • Quanterix pTau-181 LDT (plasma): Widely used ultrasensitive plasma p-tau assay for clinical evaluation and research; while not EV-specific, it serves as a performance benchmark and complementary marker in studies exploring incremental value of EV-enriched tau/Aβ.[1]

Practical takeaways

  • If the goal is to run or partner on EV-tau/Aβ assays now, NanoSomiX and NeuroDex are the most visible commercial entities pursuing neuron/astrocyte-derived EV diagnostics with infrastructure and IP; Aethlon/Exosome Sciences provides legacy proof-of-concept and potential collaboration history around exosomal tau (TauSome).[3][2][6]
  • For cutting-edge methods emphasizing exosome-bound Aβ detection and single-vesicle analytics, recent Toppan-linked detection advances and academic platforms (idICA, iMEP) indicate active development paths that could be licensed or translated with industry partners for AD diagnostics.[4][5][9][10]

⁂

  1. https://www.quanterix.com/press-releases/quanterix-launches-first-ptau-181-plasma-laboratory-developed-test-for-clinical-diagnostic-and-research-applications-in-the-us/ 
  2. https://neurodex.co/neurodex-award-addf/  
  3. https://www.aethlonmedical.com/investors/corporate-news-events/press-releases/detail/372/study-of-blood-test-to-detect-and-monitor-chronic-traumatic  
  4. https://www.holdings.toppan.com/en/news/2022/10/newsrelease20221003_1.html  
  5. https://www.nature.com/articles/s41467-019-09030-2  
  6. https://www.nanosomix.com/news  
  7. https://www.biospace.com/aethlon-medical-s-exosome-sciences-announces-the-publication-of-preliminary-findings-of-a-blood-test-to-detect-chronic-traumatic-encephalopathy-cte
  8. https://pmc.ncbi.nlm.nih.gov/articles/PMC4833534/
  9. https://pmc.ncbi.nlm.nih.gov/articles/PMC9528138/ 
  10. https://www.science.org/doi/10.1126/sciadv.abm3088 
  11. https://www.nature.com/articles/s41374-021-00644-z
  12. https://www.sciencedirect.com/science/article/pii/S0021925820481931
  13. https://www.frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2022.899944/full
  14. https://pmc.ncbi.nlm.nih.gov/articles/PMC6015111/
  15. https://pmc.ncbi.nlm.nih.gov/articles/PMC10003549/
  16. https://www.pnas.org/doi/10.1073/pnas.0603838103
  17. https://www.creative-proteomics.com/subcell/alzheimers-disease-exosome-research-solution.htm
  18. https://www.sciencedirect.com/science/article/pii/S0753332225007425
  19. https://exosome-rna.com/tag/tausome/
  20. https://exosla.com