Immunoassay Analysis and Technology Services

Immunoassays provide detection systems that record the immune response to a stimulation. The detection of soluble biomarkers by immunoassay is fundamental to many clinical trials, with these assays being used as predictive or indicative of response to drug, informative of biological mechanism and safety profiling. With a continuous investment in extensive testing capabilities, we provide comprehensive immunoassay solutions.

Broad assay and test capabilities:

Immunoassay Platforms

We have a broad soluble biomarker portfolio covering single analyte, multiplex, high sensitivity and fully automated assays using the following platforms:

• SpectraMax Plate Reader
• AushonCira-Scan
• Luminex
• Mesoscale Discovery
• Quanterix SiMoA
• Protein Simple Ella

These cutting-edge platforms are supported globally, including in China, with harmonized workflows and SOPs. We also have dedicated Immunoassay validation groups in the US, Europe and China to support the implementation of novel assays in clinical trials. Validation standards cover the use of these assays as exploratory, secondary or primary endpoints, inclusion/ exclusion criteria or reporting to clinical trial sites for patient management as a CAP/CLIA assay.

Our in-house, end-to-end laboratory services are aligned to support therapeutic areas including oncology, gastroenterology, neuroscience and vaccines. In addition to supporting standard safety testing, our dedicated laboratories offer specialized biomarkers in anatomic pathology, flow cytometry, immunoassays, molecular, genomics, CDx and PK/ADME. Since our inception, we have deployed cutting-edge technologies to support your clinical development needs and the flexibility to respond to changes as science evolves. Our scientific advisors provide consultation, even in early engagement including before a protocol, on protocol design, assay development, and companion diagnostic development, helping to assure no delay in your decision making.