Full-Service Assay Development
ICON provides industry-recognised research and development services to support technology transfers, assay development and validation via an extensive biomarker test menu and standardised analyses to monitor key molecules, targets and receptors. ICON has the resources and scientific expertise to implement a broad range of custom flow cytometric assays in clinical trials.
ICON works with sponsors to:
- Develop and/or optimise flow cytometry methodology to meet the required specifications for monitoring therapeutics
- Provide the sponsor with validation data for approval
- Rollout flow cytometric assays globally as required
- Develop a customised standard operating procedure (SOP) for performing assays globally
- Collaborate with the sponsor regarding special requirements, including secure transfer of listmode and data analysis files
- Utilise mature operational processes that optimise the sponsor’s requirements
- Precisely define the specifications for result reporting
ICON has expertise in using a variety of instrumentation platforms, and developing & validating a broad range complex flow cytometric assays under rigorous quality control procedures (see factsheet for details). Dedicated Operational staff perform ongoing clinical trial sample processing and analysis using standardised SOPs and data analysis strategies.
Global Flow Cytometry Network
Our global flow cytometry network has laboratory locations in New York, Dublin and Singapore, and all instruments are connected to a central flow cytometry server. Having a central server allows us to utilise fully harmonised and standardised processes and instrumentation for even the most complex assays. This network enables mature processes for developing, validating and implementing complex flow cytometric assays globally.
Complex flow cytometry assays
Examples of complex flow cytometry assays validated at ICON include:
- T cell and B cell subset immunophenotyping along with monocyte, granulocyte, NK, and basophil identification
- Rare event cell enumeration including detection of myeloid derived suppressor cells, dendritic cell subpopulations and blast cells
- Enumeration of circulating tumor cells and other ultra-rare events such as those measured in tetramer assays
- Receptor occupancy assays customised per study drug
- In vitro stimulation and quantification of intracellular cytokines
- Intracellular small molecule measurement, including measurement of antibody-drug-conjugates correlating to a relative amount of drug delivered per cell
- Phosphorylation assays
- MACS bead separation assays
- Antibody-Dependent Cell-mediated Cytotoxicity (ADCC) assays