The Applied/Developmental Research Directorate maintains a Clinical Services Program that has expertise covering a broad spectrum of immunologic testing and clinical trial support. Program support can begin at the early stages of clinical trial development to aid in developing a comprehensive strategy for sample collection, processing, and testing with a special emphasis on immunologic testing. Program laboratories collaborate with partners to develop customized assays or transfer existing assay technology with assay validation, data analysis and interpretation of results. Examples include:
Developing a circulating tumor cell assay to use in pharmacodynamic trial monitoring
Using bioassays to evaluate and confirm cytokine activity
Routine and customized assays of lymphocyte functional activity including proliferation, ELISPOT, and cytotoxicity assays
Establishing customized flow cytometry panels for clinical trial monitoring
The sample (whole blood or apheresis product) is delivered to the facility and processed under standardized protocols for optimal isolation of peripheral blood mononuclear cells, serum, and/or plasma samples, which are then cryopreserved.