Biomarker work that survives a regulator's questions.
Four service lines, one laboratory ecosystem — GLP, CLIA and GCLP-aligned — for pharmaceutical, biotechnology and academic programs from first hypothesis to Phase III endpoint.
Biomarker discovery & validation
Unbiased discovery of biomarkers for any indication and context of use, using neuron-enriched vesicles as the sample. We test whether your target is NDE-compatible before anyone commits a cohort, then run proteomic or transcriptomic discovery and verify the hits by orthogonal assay.
Scope a discovery study- Novel biomarker discovery
- NDE compatibility & verification testing
- Proteomic analysis of NDEs
- In-vitro drug-response biomarker discovery
Translational research biomarkers
You already have an assay that works in tissue, CSF or model systems. We translate it into an NDE-based blood biomarker and carry it through pre-clinical models into clinically relevant endpoints — pharmacodynamic, pathway engagement and treatment response — that a development team can act on.
Translate an assay- RNA sequencing
- Proteomic & lipid mass spectrometry
- PCR
- Immunoassays
Neuron-derived exosome isolation & analysis
ExoSort as a service. Send plasma; receive characterised neuron-derived vesicles, or the downstream data from them, with a report your own laboratory can build on. Custom capture markers are available for non-neuronal cell types.
About the ExoSort platform- Custom NDE isolation
- NDE quantification & characterisation
- Downstream biomarker assay integration
- Data analysis & reporting
Clinical trial biomarker support
Biomarker services built for integration into Phase I–III studies: patient stratification at screening, pharmacodynamic monitoring across visits, and endpoint analysis at read-out. Our GCLP-aligned laboratory handles multi-site and international cohorts with full traceability.
Plan a trial workstream- Stratification & enrichment
- Pharmacodynamic monitoring
- Endpoint analysis
- Panel monitoring: TDP-43, α-syn, LC3, tau/pTau, AKT, NF-L, NF-κB
Clinical testing, trial support and discovery under one roof in Natick.
Clinical testing laboratory
Develops and runs CLIA laboratory-developed tests for neurodegenerative and neurological conditions. Automated, high-precision workflows deliver clinical-grade results from plasma and serum.
Clinical trial laboratory
End-to-end biomarker analysis for clinical studies, including multi-site and international trials. Built for longitudinal cohorts: traceability, consistency, regulatory-ready data.
Research & development laboratory
Extracellular-vesicle diagnostics and neuron-derived marker discovery: early-stage research, custom assay development and translational validation for academic and industry partners.
What partners keep coming back for.
Operational rigour
GLP and CLIA compliance as the floor, not the ceiling. Every assay carries documented variability, QC and chain of custody.
Scientific precision
Immunoaffinity isolation and detection methods tuned for neuron-derived cargo, so the number you get reflects the neuron and nothing else.
Panels built per program
No catalogue tests. Panels are composed around your mechanism, your context of use and your statistical plan.
A collaborator, not a vendor
Our scientists sit in your study meetings. Results come with interpretation, and with an honest view of what the assay can and cannot claim.
Scoped proposal in five working days.
Assay options, sample requirements, timelines and budget — written by the scientist who would run the work.