Context of Use
Our Science and Services
Our expert team of recognized thought leaders have decades of experience developing, validating and implementing biomarker assays designed to meet the specific needs of context of use to support robust decision making across all phases of drug development. We have extensive experience in:
- Commercial kit optimization and implementation
- De novo assay development and validation
- Guidance on preanalytical considerations (sample collection, preparation, shipment & handling)
Our Biomarker Sciences Expertise
Biomarker Expertise
- Globally recognized Biomarker Key Opinion Leaders
- Comprehensive experience in Context of Use driven assay development and validation that ensures your assay delivers decision-enabling data
- Expertise in regulated and non-regulated biomarker analysis in support of discovery research projects, preclinical toxicology and clinical studies
Dedicated Biomarker Laboratory
- Designed and built for ligand binding based biomarker assays
- Commercially available assays for clinical study
- Guidance on sample collection, preparation, handling, and analysis
- Dedicated Critical Reagent team
De novo Assay Development
- Ligand binding assays
- Targeted qPCR assays
- Target Engagement & Mechanism of Action assays
- Pharmacodynamic assays
- Ex-vivo Stimulation
Off-the-Shelf Assays
Immunologix Labs is excited to provide a number of off-the-shelf assays including the ProteinSimple ELLA Neurofilament Light assay, MSD V-PLEX Proinflammatory Panel 1 and MSD V-PLEX Chemokine Panel 1. These assays are supported by a comprehensive analytical performance package designed to meet the needs of varied contexts of use. In addition to delivering impeccable precision, our comprehensive approach aligns biomarker analysis with specific context of use by fully evaluating how these methods perform with endogenous molecules in real samples. This brings a level of confidence to your analysis that cannot be achieved using surrogate molecules and matrix as typically quoted in manufacturer claims.
Instruments used in Biomarker Sciences
Spectramax 384
Dependable, rugged ligand binding assay platform
Perkin Elmer Envision
Provides critical support for select targeted assays.
Hamilton Starlet
Automated sample preparation and assay method execution, providing consistent and wide-range liquid handling steps.
Mesoscale Discovery Sector Imager 600
Rugged, redundant platform for ECL single and multiplex kits
Protein Simple Ella
Highly automated microfluidics cartridge platform capturing multiple analytes in single sample preparation
Diseases/Therapeutic Areas
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Allergy
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Asthma
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Anemia
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Bone metabolism
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Cardiovascular
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Diabetes
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Growth
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Inflammation & immunology
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Metabolic
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Endocrinology
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Inflammation & immunology
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Spinal muscular atrophy
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Multiple sclerosis
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Alzheimer’s disease
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Muscle diseases
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Oncology
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COPD
Matrices
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Serum, plasma
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Whole blood
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CSF
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Urine
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Saliva
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Sputum
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Broncheolar lavage fluid
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Nasal aspirate
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Nasopharyngeal aspirate
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Tears
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Synovial fluid
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Vitreous humor
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Aqueous humor
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Semen
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Blister fluid
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Tissue lysates
Individual Analytes
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anti-KLH lgG
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anti-KLH lgM
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C-peptide
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C-kit
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CCL-24/Eotaxin-2
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CCL27/CTACK
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CD73
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CSFR1
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CXCL13
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Eotaxin 1/CCL11
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Eotaxin 3/CCL26
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GFAP - Ultrasensative
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GM-CSF/CSF2
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Glucagon
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Glucokinase
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Insulin
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IFN-γ
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IGF1
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IL-10/CSIF
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IL-12/IL-23p40
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IL-12p70
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IL-13
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IL-15
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IL-16/LCF
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IL-17a
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IL-1a
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IL-1β / leukocytic pyrogen
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IL-2/TCGF
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IL-2Ra/CD25
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IL-4
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IL-5
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IL-6
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IL-7
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IL-8 (HA)
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IL-8
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IP-10
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ITAC
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Kallikrein (multiple)
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MCP-1
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MCP-4/CCL13
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M-CSF/CSF1
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MDC/CCL22
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MIP-1α
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MIP-1β
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Neurogranin
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NF-H
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NF-L Ultrasensative
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Periostin
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Osteopontin
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sCD40
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sCD40-Ligand
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sCD73/5NT
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SCF
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NF-L Ultrasensitive
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Placental Growth Factor (PlGF)/PGF
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PARC
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TARC/CCL17
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TNF-b
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TNF-α
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Transthyretin (TTR) VEGF
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TREM2
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VEGF
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YKL40
Multiplex Panels
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V-Plex Chemokine Panel 1
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V-Plex Cytokine Panel 1
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V-Plex Pro-Inflammatory Panel 1
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V-Plex Th17 Panel
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V-Plex Abeta Peptide Panel 1
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V-Plex Neuroinflammation Panel 1
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V-Plex Angiogenesis Panel
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V-Plex Vascular Injury Panel
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V-Plex NHP Cytokine Panel
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Multiple Luminex Panels – please enquire
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Multiplex and Multianalyte ELLA Panels