Clinical Support Laboratory

Overview

The Clinical Support Laboratory provides clinical trial processing support to the National Cancer Institute and performs sample testing with an emphasis on immune function. 

We work with National Cancer Institute investigators on immune status of clinical trial subjects treated with anti-cancer immune modulators.   

The laboratory provides custom services on immune function testing and immunophenotyping support to principal investigators working on intramural clinical trials in the National Cancer Institute, though assessments may also be performed for other trials.  

The Clinical Support Laboratory is known for high-quality biomarker tests, often performed in multiplex, as well as immunogenicity (anti-drug antibody) assays. The laboratory is CLIA-certified to perform high-complexity assays.  

Innovations

  • Supported CD22 CAR-T trial and measured 15 markers of cytokine storm vs. hallmarks of a related illness, Hemophagocytic lymphohistiocytosis. 
  • Supported HER-2 vaccine follow-up with multi-color ELISPOT, an extremely sensitive method used to detect low frequencies of antigen-reactive T cells to both IFN-g and Granzyme B.  

Focus

Clinical trials processing section 

  • Receive, process, preserve, and record clinical trial samples. 
  • Provide materials for real-time testing by other sections in the laboratory. 
  • Perform special techniques including separating cell populations with magnetic beads and isolating DNA and RNA from some samples with commercially available kit technology. 

Cell-mediated immunity section 

  • Develop cell-based assays and provide immunological monitoring. 
  • Use fully developed assays that evaluate adaptive immunity:  
    • Cellular proliferation 
    • Antibody-dependent cell-mediated cytotoxicity (ADCC) 
    • NK cell-mediated cytotoxicity 
    • Single & Multiplex enzyme-linked immunospot (ELISPOT) assays 
    • Live-cell metabolic assays 

Flow cytometry section 

  • Analyze cell-surface markers and intracellular markers such as cytokines and transcription factors. 
  • Perform tetramer staining. 
  • Measure intracellular kinase activity. 
  • Perform cell cycle analysis on clinical samples. 
  • Analyze samples from simian immunodeficiency virus (SIV)–infected nonhuman primates. 
  • Provide flow cytometry services to investigators. 

Cytokine testing section 

  • Perform a wide range of assays for soluble biomarkers that include: 
    • Cytokines 
    • Chemokines 
    • Soluble receptors 
    • Other biomarkers 
  • Provide Meso Scale Discovery and Luminex assay platforms for testing, which enable increased sensitivity, shortened turn-around time, and enhanced cost-effectiveness. 

Cell culture section 

  • Perform propagation of human cell lines and transfection. 
  • Prepare primary cultures from human punch biopsies to generate primary fibroblast cell lines. 
  • Provide human B-cell immortalization using Epstein-Barr virus.