Assay Development

ExosomeDx provides a wide-ranging approach to assay development.

Development of Known Biomarker(s) into a Targeted Assay

If a biomarker has already been identified it can become a shorter development path to a companion diagnostic (CDx). These biomarkers are typically used for patient stratification and to identify individuals likely to  respond to  particular therapeutics. 

Target Engagement

Exosomal biomarkers can serve as indicators of target engagement via gene expression analysis.  When a therapeutic ‘hits’ its biological target, specific genes may become activated and can be used as biomarkers to determine drug efficacy. 

Longitudinal Monitoring

Longitudinal monitoring allows physicians to observe how patients respond during therapy and assess if the treatment regimen needs to be modified or replaced with a secondary therapeutic. Often, the biomarker that identifies treatment ‘responders’ is the same biomarker that is utilized for longitudinal monitoring.  Additionally, biomarkers that demonstrate target engagement are also used for longitudinal monitoring.  

Liquid biopsy assessment of exosomal biomarkers avoids two common obstacles during post-treatment longitudinal monitoring: access to tissue and biomarker identification using small amounts of blood. Exosome Diagnostics’ technology platform provides the requisite sensitivity as low as 0.5 mL of plasma.

Characterization of Clinical Trial Patients (Retrospective Testing)

Restrospective testing of clinical trials or biobanked samples allows for further analysis. Properly stored samples have shown to be stable for greater than 20 years when using our exosome isolation methods.


Looking for a biomarker?

Need an assay developed?

Run Clinical Assays at Exosome Diagnostics

We specialize in various methods for biomarker identification

  • Long RNA seq platform, Open Array Panel(s), NGS mutation detection panel, and/or custom panels
  • Our bioinformatics pipeline is the leader in liquid biopsy analysis

Collaborate with our experts to meet your needs for assay development and design

  • We provide hands-on involvement to develop biomarker(s) as a distinct and custom targeted assay
  • The available assays include targeted NGS, ddPCR, or qPCR based test

Experienced in handling clinical samples in our certified facilities

  • We specialize in planning and validating clinical assays, along with regulatory and operational requirements