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Autoimmune disease testing capabilities

ICON Laboratories provides comprehensive autoimmune testing solutions to support global clinical development programmes across a broad range of immune-mediated diseases. 

Leveraging a harmonised global laboratory network, deep scientific expertise and advanced diagnostic technologies, we help sponsors identify, stratify and monitor patients while generating high-quality, decision-ready data to inform development decisions. 

With extensive experience supporting autoimmune clinical trials across multiple therapeutic areas and development phases, ICON has delivered laboratory support for studies spanning rheumatology, neuroimmunology, gastroenterology, endocrine autoimmune disorders, autoimmune haematology and dermatology, enabling sponsors to advance innovative therapies with confidence.

Comprehensive autoimmune testing portfolio

The laboratory network supports studies in conditions including:

  • Systemic lupus erythematosus (SLE) and lupus nephritis
  • Rheumatoid arthritis (RA)
  • Psoriatic arthritis (PsA)
  • Ankylosing spondylitis and axial spondyloarthritis
  • Sjögren’s syndrome
  • Systemic sclerosis
  • Idiopathic inflammatory myopathies
  • Multiple sclerosis
  • Myasthenia gravis
  • Inflammatory bowel disease (IBD)
  • Coeliac disease
  • Graves’ disease
  • Type 1 diabetes
  • Autoimmune haematological disorders and additional immune-mediated conditions 

Advanced autoimmune testing with the Phadia™ 250 platform

ICON has implemented the Thermo Fisher Scientific Phadia™ 250 platform within its central laboratories. This fully automated fluoroenzyme immunoassay (FEIA) system supports both ImmunoCAP® allergy testing and EliA® autoimmunity testing on a single platform. The system offers:

  • Broad autoimmune biomarker coverage with more than 50 autoimmune markers
  • IVD assays with regulatory status dependent on region
  • Standardised, highly automated workflows
  • Continuous random-access processing
  • Throughput of up to 60 results per hour
  • Quantitative and semi-quantitative antibody measurement
  • Integrated laboratory information system connectivity and reporting

Benefits for clinical development programmes:

Broad testing capabilities

Access to a wide portfolio of ImmunoCAP allergy assays and EliA autoantibody assays across multiple allergy and autoimmune disease areas.

Automated laboratory workflows

Fully automated processing supports standardised laboratory workflows and reduces reliance on manual processing for selected autoantibody tests.

Study-aligned biomarker testing

Testing may support participant characterisation, protocol-defined eligibility assessment, disease subgroup analysis and exploratory biomarker investigations, where scientifically appropriate.

Scientific consultation

ICON's scientific teams align assay selection with study objectives, patient populations, and biomarker strategies to support high-quality, decision-ready data.

Initial implementation of the Phadia™ 250 is at ICON’s central laboratories in Dublin, Ireland, and Farmingdale, New York, US. ICON’s wider central laboratory footprint, including China, provides additional opportunities to support regional and global studies, with assay availability confirmed according to study requirements.

Contact ICON to confirm turnaround times and assay-specific specimen requirements. Accepted specimen types, anticoagulants, minimum volumes, and stability requirements vary by assay.

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