Our Immunoassay Platforms

We leverage state-of-the-art platforms - each selected for its precision, sensitivity, and scalability - enabling robust support for your clinical development programs.

• DxI 9000 Immunoassay Analyzer — Beckman Coulter, Inc.
  High-sensitivity, high-throughput automation for routine and complex immunoassays.
• MESO SECTOR® S 600MM — Meso Scale Diagnostics, LLC (MSD)
  Multiplex electrochemiluminescence detection for cytokine profiling and biomarker quantification.
• SpectraMax® iD5e Multi-Mode Microplate Reader — Molecular Devices, LLC
  Flexible detection modes for absorbance, fluorescence, and luminescence-based assays.
• Ella™ Automated ELISA Platform — Bio-Techne Ltd.
  Hands-free, cartridge-based ELISA system for rapid and precise protein quantification.
• FLEXMAP 3D® Instrument System — Luminex Corporation
  Platform uses both magnetic and non-magnetic microspheres and is capable of simultaneously measuring up to 500 genes or proteins from a small sample.
• Octet® SF3 | Surface Plasmon Resonance — Sartorius AG
  Accurate measurement of molecule kinetics and affinity from a single analyte concentration

Pre-validated Immunoassays to Streamline Development

Our ready-to-deploy assays are designed to reduce development timelines and support critical decision-making across the clinical trial lifecycle.

Enrollment Assays

Purpose: Identify pre-existing immunity to gene therapy vectors

• Detect total antibodies (TAb) and neutralizing antibodies (NAb) against AAV vectors

Immunogenicity Assays

Purpose: Assess immune responses to biologics and cell therapies

• Anti-drug antibody (ADA) assays: screening, confirmatory, and neutralizing formats
• NAb assays for CAR-T therapies targeting CD19 and BCMA

Monitoring & Predictive Biomarkers

Purpose: Track disease progression and therapeutic response

• APOE4 (Apolipoprotein E)
• aSyn (α-Synuclein)
• GFAP (Glial Fibrillary Acidic Protein)
• NfL (Neurofilament Light Chain)
• p-Tau 217 (Phosphorylated Tau at Threonine 217)

Inflammation & Cytokine Release Syndrome (CRS) Panels

Purpose: Monitor immune activation and inflammatory responses

• Panel 1: IFN-γ, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, IL-13, TNFα
• Panel 2: IFN-γ, IL-2, IL-6, IL-8, IL-10, IL-12p70, IL-15, IL-18, MIP-1α, TNFα

End-to-End Expertise in Ligand-Binding Assay Development

Our scientific team brings deep expertise in the design, development, and validation of ligand-binding assays tailored to your clinical program’s needs. We support a wide range of applications, including:

• Pharmacokinetic (PK) and Pharmacodynamic (PD) Endpoints — Quantitative assays to evaluate drug exposure and biological response.
• Immunogenicity Assessment — Comprehensive ADA and NAb testing strategies for biologics and gene & cell therapies.
• Patient Selection & Stratification — Assays developed in compliance with IDE and IVDR requirements to support enrollment criteria.
• Neurodegenerative Biomarker Detection — Ultra-sensitive assays for detecting CNS biomarkers in peripheral blood.
• Enzymatic Activity Assays — Specialized methods for evaluating enzyme replacement therapies (ERT) in rare genetic disorders.

Regulatory Alignment & Clinical Trial Support

We have extensive experience supporting Phase I–III clinical trials, ensuring that all assay strategies are:

• Scientifically robust and validated
• Aligned with health authority (HA) expectations
• Fit-for-purpose across all stages of drug development

Many of our assays have received IDE and PSA approvals, backed by comprehensive validation study reports.