Biomarker Discovery Services

Neurodex specializes in developing EV-based blood biomarkers to select patients and monitor treatment response in clinical trials. We offer Biomarker Discovery Services for neurology using advanced EV technologies to deliver accurate and reliable results. Our extensive expertise in targeted EV isolation and characterization combined with immunoassay validation and development enables high-quality solutions to complex problems. Our GLP-compliant and CLIA-licenced facilities allow partnering from the early stages of research to clinical implementation.


Biomarker Discovery in Drug Development

Precision medicine relies on biomarkers to identify subpopulation(s) for targeted therapies. Blood biomarkers enable broad populational screening to identify patients best suited for clinical trials in a timely, cost-effective manner.

Clinical trials using biomarkers to identify target engagement provide an accurate measure of druggability for a given target and drug efficacy. Blood biomarkers permit repeated non-invasive tests and thus facilitate better clinical trial design, reducing cost and increasing success rate.

Biomarkers can be used as an outcome for clinical trials; recent FDA approvals for AD and ALS drugs are based on biomarkers alone (accelerated approval). Incorporating biomarker discovery in drug development can streamline the creation of crucial therapies.


Ensuring Data Accuracy and Reliability

To accelerate biomarker discovery programs, NeuroDex offers the following services:

Biomarker Discovery

  • Specialized expertise as a leader in Exosome-based R&D
  • Assay optimization, qualification, and full analytical validation
  • Biomarker discovery using diverse models: cell culture, mice, NHP, and humans. 

Clinical Trial Biomarkers

  • GLP-compliant operations
  • QMS with full quality assurance
  • QC for all reagents and analytical variability
  • Support of small and large clinical trials


We offer two approaches to Biomarker Discovery

ExoSORT - neuron-derived exosome isolation technology

ExoSORT is Neurodex’s proprietary immunoaffinity platform for isolating extracellular vesicles (EVs) from plasma samples. A unique antibody combination is used to capture neuron-derived EVs upstream of protein and RNA analysis, improving the blood biomarker’s specificity towards neurons.

  • Provides a liquid biopsy for the brain pathologies
  • Compatible with EDTA plasma and serum
  • Only 0.5-1.0 mL of sample required 
  • Allows a broad range of downstream analyses: RNAseq, qPCR, LC-MS, and diverse immunoassay platforms.
  • Multiple protein and RNA assays from a single 0.5-1.0 mL sample


LuminEV

An intact extracellular vesicle immunoassay based on the Luminex platform. Antibodies against specific surface markers are conjugated to index beads and used to capture extracellular vesicles directly from diluted plasma samples.

  • Efficient multiplexing.
  • Protin co-localization analysis
  • Only 100 ul of sample is required
  • Allows semi-quantitative and comparative analyses
  • Bypasses the bias introduced by EV isolation techniques

Contact Our Biomarker Discovery Services Team

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