Applications

Immunotherapy

Molecular & genomics bioassay capabilities for clinical immunotherapy studies:

• Predictive biomarker assays (whole exome or RNA sequencing)
• qPCR or microarray-based RNA expression assays
• Gene expression profiles for detecting and characterizing mutations/biomarkers in cancer cells with Nanostring technology.
• Comprehensive targeted NGS panels or tumor profiling assays to detect known and emerging biomarkers, and measure tumor mutational burden

Analytical technologies and methods for CAR T-Cell Therapy development:

• Flow cytometric methods for:
  • Lymphocyte differentiation, and analysis of intracellular cytokines
  • CAR T-cell detection and quantification in PBMCs
• Enzyme-linked Immunospot (ELISpot) analysis for characterizing specific T- or B-cell responses.
• Measurement of gene expressions performed by qPCR.
• Immunoassays (ELISA, MSD, Luminex) to measure cytokines and potential ADAs

A broad portfolio of clinically relevant testing services to aid in viral vector-based gene therapy development:

• Cell-based assays for immune function and proliferation
• Quantitative analysis of viral shedding by qPCR for safety testing to assess potential for transmission
• Transgene or target protein expression
• Detection and quantification of the viral genome in serum (or target tissue)
• Assays for measuring anti-drug antibodies (ADA) against the oncolytic virus
• Neutralizing Antibody (NAb) assays to test for neutralizing activity against the vector of gene therapy

Anti-drug Antibodies (ADAs)

Many targeted anticancer agents and immunotherapies are biological drugs that may trigger immune responses leading to the formation of antidrug antibodies (ADAs). ADAs are directed against immunogenic parts of the drug and may affect efficacy and safety. In order to determine this relevance, the possible effects of ADAs on pharmacokinetics, efficacy, and safety parameters need to be investigated.  We understand the challenges in ADA detection and are skilled at developing, validating, standardizing, and transferring these assays.

Chronic Viral Infection Testing for Immunotherapy Trials:

• Human Immunodeficiency virus (HIV)
• Hepatitis B virus (HBV)
• Hepatitis C virus (HCV)
• Human T-lymphotropic virus (HTLV)
• Cytomegalovirus (CMV)
• Epstein-Barr virus (EBV)
• Adenovirus (ADV)
• Human herpesvirus (HHV-6, HHV-7, HHV-8)
• BK virus (BKV)
• John Cunningham (JC) virus