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Efficacy & Specialty Assay Modules

Efficacy Specialty Modules

Advanced efficacy modules provide direct, quantitative, and mechanism-based evidence proving that a drug produces its intended therapeutic effect. Safety establishes whether a drug causes adverse effects, while efficacy confirms its ability to deliver meaningful therapeutic benefit.

These modules are designed to generate quantitative, imaging, and analytical data confirming treatment response, provide documentation for funding, patents, publications, and pharmaceutical partnerships, and define or validate the mechanism of action, such as metabolic effects, pancreatic repair, anti-inflammatory pathways, neuroprotection, or anticancer activity. As with safety modules, not all efficacy modules are required; selection is mechanism-driven, and typically, one to two modules are sufficient to meet these objectives.

General physiological data from early stages describe what happens to the animal, but do not prove disease improvement. Early-stage studies focus on understanding the animal’s response, whereas efficacy modules systematically assess whether the drug meaningfully improved the disease and elucidate its underlying mechanism of action. These modules:

  • Therapeutic Outcome Focus: Measuring disease-specific improvements, not general signs.
  • Multi-Level Analysis: Evaluating drug effects at cellular, tissue, and molecular levels.
  • Signal Specificity: Distinguishing true pharmacological effects from nonspecific changes.
  • Tailored Integration: Modules, tissues, and assays uniquely combined per disease model.
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    Veterinary Industry Innovation

    1

    Inflammatory Pathway Assessment

    The Inflammatory Axis is a foundational component of our preclinical analysis, designed to evaluate the role of systemic and localized inflammation in diseases such as cancer, stroke, diabetes, and neurodegenerative disorders. By quantifying key cytokines (e.g., IL‑6, TNF‑α, IL‑1β, IL‑10) and immune cell markers such as CD68, Iba1, and GFAP, we provide detailed insights into a drug’s impact on pro‑inflammatory signaling, immune cell activity, and NF‑κB pathway activation. This axis is essential for developing targeted anti‑inflammatory therapies and understanding how drug candidates modulate immune responses across a range of inflammatory-driven conditions.

    Key Biomarkers & Methods:

    • Cytokine profiling panels (IL‑6, TNF‑α, IL‑1β, IL‑10)
    • Macrophage & microglia markers (CD68, Iba1, GFAP)
    • NF‑κB activation assays
    Veterinary Industry Innovation

    2

    Oxidative Stress & Antioxidant Profiling

    The Oxidative Stress Axis quantifies the imbalance between reactive oxygen species (ROS) and antioxidant capacity, a key driver of tissue damage in liver disease, kidney injury, neurological disorders, and metabolic syndromes. Through assays measuring MDA, SOD, GSH/GSSG ratios, and ROS levels, we evaluate a drug’s ability to mitigate oxidative damage and enhance cellular antioxidant defenses. This axis provides critical data for therapies targeting neurodegeneration, organ injury, cardiovascular disease, and metabolic dysfunction, where oxidative stress significantly contributes to disease progression.

    Key Biomarkers & Methods:

    • Lipid peroxidation marker (MDA)
    • Antioxidant enzyme activity (SOD)
    • Redox status (GSH/GSSG ratio) and ROS quantification assays
    Veterinary Industry Innovation

    3

    Metabolic Function & Hormonal Analysis

    Our Metabolic Axis offers comprehensive profiling for metabolic disorders such as diabetes, obesity, NAFLD/NASH, and endocrine dysfunction. By integrating oral glucose tolerance tests (OGTT), insulin tolerance tests (ITT), lipid metabolism panels, and hormonal assays (insulin, leptin, adiponectin, cortisol), we assess how a drug influences energy homeostasis, insulin sensitivity, and lipid metabolism. This axis is crucial for evaluating drug candidates in metabolic disease models and supports the development of therapies that restore metabolic balance.

    • Key Biomarkers & Methods:
    • Glucose regulation tests (OGTT, ITT)
    • Lipid metabolism profiling
    • Hormonal assays (insulin, leptin, adiponectin, cortisol)
    Veterinary Industry Innovation

    4

    Fibrosis & Extracellular Matrix Evaluation

    The Fibrosis & ECM Remodeling Axis focuses on quantifying fibrotic progression and extracellular matrix (ECM) changes in chronic conditions such as liver fibrosis, kidney disease, pulmonary fibrosis, heart failure, and gastrointestinal fibrosis. Using histological staining (Masson’s trichrome, Sirius Red) and molecular markers including α‑SMA and collagen I/III, we determine whether a therapeutic intervention can prevent, halt, or reverse fibrotic tissue remodeling. This axis provides essential structural and molecular endpoints for anti‑fibrotic drug development.

    Key Biomarkers & Methods:

    • Histological stains (Masson’s Trichrome, Sirius Red)
    • Fibrosis markers (α‑SMA, collagen I/III)
    Veterinary Industry Innovation

    5

    Apoptosis & Cellular Proliferation Monitoring

    The Apoptosis & Cell Turnover Axis measures the balance between programmed cell death and cellular proliferation in oncology, neurodegeneration, liver injury, kidney disease, and cardiac damage. Through assays such as caspase‑3 activity, Ki‑67 proliferation index, and TUNEL staining, we evaluate whether a drug promotes cell survival, inhibits abnormal proliferation, or modulates apoptotic pathways. This axis delivers critical insights into a drug’s impact on cellular fate, supporting therapeutic strategies for cancer, neuroprotection, and organ repair.

    Key Biomarkers & Methods:

    • Caspase‑3 activity assay
    • Ki‑67 proliferation marker
    • TUNEL assay for apoptosis detection
    Veterinary Industry Innovation

    6

    Vascular Function & Angiogenesis Studies

    The Vascular & Endothelial Axis evaluates drug effects on blood vessel formation, stability, and endothelial health in cardiovascular disease, stroke, cancer, and tissue regeneration models. By measuring CD31 (endothelial marker), VEGF expression, and performing angiogenesis and vascular integrity assays, we determine a compound’s ability to modulate vascular growth, barrier function, and endothelial signaling. This axis is vital for developing therapies targeting vascular dysfunction, ischemia, tumor angiogenesis, and inflammatory vascular injury.

    Key Biomarkers & Methods:

    • Endothelial marker (CD31)
    • VEGF expression and secretion analysis
    • Angiogenesis and vascular integrity assays
    Veterinary Industry Innovation

    7

    Immune Response & Activation Profiling

    The Immune Activation Axis maps adaptive immune responses critical for cancer immunotherapy, autoimmune disease, vaccine development, and systemic inflammatory disorders. Using T‑cell subset profiling and comprehensive flow cytometry panels, we track drug‑induced changes in immune cell populations, activation states, and cytokine profiles. This axis enables the development of precise immunomodulatory strategies, providing a detailed understanding of how drug candidates shape cellular immunity and immune‑driven therapeutic outcomes.

    Key Biomarkers & Methods:

    • T‑cell subset profiling
    • Immune phenotyping via flow cytometry panels