ADx Clinical Trial Services:
Laboratory Services
Specialization, Our Key to Excellence
View our clinical translational test menu.
Immunotoxicity
Assessment of acquired and innate immune responses to determine safety and efficacy is vital to successful product development and clinical studies. New biopharmaceuticals require a new class of laboratory tests to assess efficacy and safety. Between the Complement Laboratory, long recognized as a worldwide center of excellence, and the Immunology Laboratory, we offer a comprehensive menu of tests and services for centralized, cost effective characterization of immunologic responses to treatment.
Immune Cell Functions
- ELISpot assays to measure frequency of antigen-specific T cells
- Analysis of leukocyte phenotype by multicolor flow cytometry
- Intracellular cytokine staining
- Functional cytotoxicity assays for natural killer (NK) and T cells, including antibody dependent cell-mediated cytotoxicity (ADCC)
- Antigen-specific lymphocyte proliferation assays customized to the client's needs
- Basophil activation studies (e.g. allergens or drugs)
- Phosphoflow customized to signaling molecule of choice
Antibody Activity
- Antibody responses to novel antigens
- Measurement of adverse antibody responses, including IgG, IgM and IgE
- Measurement of immuno-complex formation
Inflammatory Response
- Cytokine measurement: serum, plasma, sputum, and intracellular
- Toll-like receptor (TLR) functional assays
Complement Activation and Inhibition
- Evaluation of complement activation by measurement of activation products: C3a, C4a, C5a, Bb, SC5b-9 as well as iC3b and C4d
- In vitro evaluation of the complement activating potential of new compounds, biomaterials or other substances, using serum or whole blood from human donors as well as many animal species
- Measurement of autoantibodies against complement components: C1q Ab, C1Inh Ab, C3 nephritic factor
- Complement functional screens and comprehensive assays for function and concentration of individual components and regulatory factors
- GLP studies can be conducted for complement testing in a number of non-human species from pre-clinical trials, as well as in vitro studies
Infectious Disease
ADx has well-developed clinical study capabilities for monitoring infectious organisms, pharmacokinetic evaluation of anti-microbials, and assessing treatment effects. The Mycobacteriology Laboratory is recognized worldwide for expertise in tuberculosis and non-tuberculosis identification and drug sensitivity testing.
Services include a large menu of molecular diagnostic tests for pathogens, traditional microbiology and serology, and a pharmacokinetics group providing crucial services in measurement of drug levels by HPLC and mass spectrometry.
Companion Diagnostics for Personalized Medicine
National Jewish Health is pursuing discovery and development of biomarkers with applications to patient treatment stratification. Built around a portfolio of internally developed biomarkers, and state-of-the-art molecular diagnostics and mass spectrometry facilities, ADx can offer high throughput real-time PCR, multiplex genotyping, proteomics, and metabolomics and assays to measure drug levels and in vitro drug sensitivities. ADx actively seeks partnerships for biomarker development through commercialization. The Biorepository at National Jewish Health provides access to extensively characterized patient samples from defined disease states.
