We specialize in custom assay development and validation tailored to your study’s unique requirements. You can rely on our expertise to deliver accurate, timely results and flexible assay solutions that support every phase of clinical development.

 

With over 3,000 validated tests and access to 16+ analytical platforms, we offer unmatched versatility in specimen types and testing methodologies—ensuring your assay is optimized for performance, compliance, and scalability.

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End-to-End Assay Development Expertise

As your clinical trial assay development partner, we provide:

  • Custom assay design, optimization, and validation

  • Transfer of existing assays into our high-throughput lab environment

  • Risk mitigation strategies to keep your program on track and on time

Our team has deep experience validating both custom assays and commercially available kits, with the ability to transition validated assays into our clinical lab for high-volume testing.

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Technologies & Platforms We Support

We leverage industry-leading platforms and technologies to deliver robust, regulatory-ready data:

  • Immunoassays for anti-drug antibodies (ADA) and neutralizing antibodies (NAb)

  • ELISA-based biomarker assays (e.g., IL-2, IL-8 release for PD-1/PD-L1, CTLA-4, OX-40)

  • ELISpot assays for cytokine secretion and proliferation

  • qPCR/ddPCR for RCL/RCR testing, viral load, biodistribution, and shedding

  • NGS & Sanger sequencing for gene expression, predictive biomarkers, and viral genotyping

  • Nanostring for digital gene expression and immune profiling

  • Flow Cytometry & ELISpot for cell-based immunogenicity and cytokine release syndrome (CRS) detection

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Flexible Validation Models

We offer three tailored validation pathways to meet your study’s needs:

  • Custom/Fit-for-Purpose: Full development and validation for novel assays

  • Partially Validated Transfer: Optimization and validation of assays with prior client data

  • Fully Validated Transfer: Pre-validation and validation based on client-provided SOPs and reports