Companion Diagnostic Assay Development and Validation
Bringing a therapeutic to market often requires a companion diagnostic (CDx) to identify eligible patients or monitor treatment response. Accelevir provides CDx assay development and validation in collaboration with diagnostic partners, leveraging our CLIA-certified, GLP-capable laboratory.
Technical Capabilities:
- Molecular CDx development for gene therapy and targeted therapeutics.
- Immune-based CDx assays (flow cytometry, ELISpot, multiplex).
- Analytical validation to FDA and IVD standards.
- Integration with clinical trial biomarker strategies.
Why Partner with Accelevir:
- Experience in co-development with biopharma and diagnostic companies.
- End-to-end molecular and immune CDx workflows in one lab.