Inotiv’s toxicogenomics studies are a powerful tool for the safety assessment of preclinical candidates, as well as novel small molecule and commodity chemicals. Data can be used to:

  • Establish mode-of-action (MOA) for target and off-target effects
  • Identify early potential liabilities of preclinical candidates in pharmaceutical development
  • Identify common response pathway(s) for development of gene signature biomarkers
  • Enable early safety assessment in discovery toxicology using high-throughput targeted gene expression
  • Determine quantitative benchmark dose (BMD) relationships between-dose and gene-expression based pathway responses for use in risk assessments

Our experimental designs for toxicogenomic studies employ dose-response studies — from human-relevant levels to exposure levels used in regulatory studies — with a focus on identifying no-observed-effect level (NOEL) and benchmark doses useful in risk assessments, as well as determining thresholds of toxicological concern.

With a deep background in toxicogenomics and genetic and molecular toxicology, our team conducts studies aimed at identifying cellular and genomic response pathways to xenobiotic exposures.

Our fully integrated capabilities deliver turnkey toxicology solutions that include gene expression profiling integrated into traditional studies. We design studies for:

  • Optimal downstream statistical evaluation
  • Processing samples by next-generation sequencing
  • Bioinformatics support to determine biological relevance and significance of the data
  • A comprehensive investigative toxicology approach to assess MOA
  • Applying computational tools using a broad spectrum of in vitro and in vivo test systems
  • Integrating genomic profiling into traditional toxicology studies
  • Integrating traditional apical endpoints with histology and pathology support

Inotiv’s scientific staff has the expertise to provide a comprehensive investigative toxicology approach to assess MOA. We integrate genomic profiling into traditional toxicology studies and apply computational tools using a broad spectrum of in vitro and in vivo models.

Our studies provide data in a timely manner to improve your understanding of potential adverse effects. We ensure you understand how the data are relevant to humans to facilitate informed decision-making.

To talk to an expert about our Toxicogenomic Services, please click here.

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Nucleic Acid Purification and Analysis

  • Isolation of RNA or DNA from animal tissues, blood, cultured cells, and formalin-fixed, paraffin-embedded (FFPE) tissue
  • Agilent Bioanalyzer assessment of nucleic acid purity and integrity
  • Agarose and PAGE gel electrophoresis

Next-Generation Sequencing Technology

  • Illumina NextSeq® 500
  • DNA and RNA library preparation
  • Whole transcriptome sequencing (RNA-Seq)
  • Preparation of libraries from FFPE-derived DNA/RNA
  • Whole exome and amplicon DNA-Seq 
  • High-throughput targeted gene expression

Gene Expression/Detection Via PCR

  • Quantitative real-time PCR (TaqMan® and SYBR® Green chemistries)
  • Applied Biosystems microfluidic arrays
  • Detection and quantitation of specific mRNA and lncRNA species
  • Design of PCR assays for use with samples from FFPE tissues
  • Design of complex PCR assays for genes with significant homology to other genes or pseudogenes
  • Bioinformatics support

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