Unparalleled Experience in Gene Expression

At CGI, we understand the advantages and utility of gene expression profiling in drug development. Well-designed studies can have a major impact on drug development. Our scientists have extensive experience working with clients to develop optimal study designs, sample collection protocols, and strategic application of gene expression in clinical studies for identifying the molecular signature of a disease and for correlating a pharmacodynamic marker with the dose dependent cellular responses to exposure of a drug (pharmacogenomics, PGx).

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Summary of Gene Expression Services Offered:

  • mRNA-Seq
  • Total RNA-Seq
  • FFPE RNA-Seq
  • Fusion detection
  • Tissue of origin (TOO) determination
  • Alternative splicing events
  • Toxicogenomics
  • Microarray
  • qPCR
  • Custom expression panels

Applications of Gene Expression Profiling
in Clinical Trial Patient Populations

  • Safety
    • Expression profiling of drug metabolizing enzymes
    • Identify quantitative biomarkers that can be used both in early clinical trials to indicate effect and guide dose and  regimen decision
    • Identify biomarkers of adverse effects prior to clinical onset of toxicity
  • Efficacy
    • Identification of appropriate gene profiles needed to maximize therapeutic efficacy
    • Identify optimal patient population for successful clinical trials
    • Confirm stimulation/suppression of intended therapeutic target in patient populations
  • Development and Label Expansion
    • Whole transcriptome expression profiling combined with clinical outcomes to identify novel therapeutic targets
    • Neoantigen discovery/detection

    All of our expression analyses are available for integration into clinical studies. Custom assay development and validation services are offered to address client-specific requests. CGI applies rigorous quality standards, including GLP and CLIA, to all studies in order to ensure the highest quality data is generated and reported. We are able to quantify gene expression in a broad spectrum of tissue samples, including formalin fixed paraffin embedded (FFPE) tissues specimens.

CGI offers multiple pre-optimized, validated panels for:

Platforms Applications
  • Next Generation Sequencing (NGS)
  • qPCR
  • Affymetrix Microarray
  • NanoString nCounter®
  • Archer® FusionPlex®
  •  Oncology
  • CYP450 isozyme expression
  • Cell membrane transporters
  • Client customized gene panels