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CNS and neurology

Biomarker-driven diagnostics for Alzheimer’s disease and neurodegenerative disorders

Identifying the right patients in CNS trials remains one of the biggest challenges in drug development. Blood-based biomarkers are now transforming this landscape—offering a minimally invasive approach to support earlier detection of underlying pathology, improve access to evaluation, and enhance patient identification for clinical research and therapeutic development. In defined clinical settings, these biomarkers have demonstrated correlation with Alzheimer’s pathology and concordance with amyloid PET and CSF measures. 

 ICON’s expanded CNS biomarker capabilities combine blood-based testing, CSF analysis, and genetic profiling to support more precise patient selection and stronger study outcomes.

Our high-quality assay menu spans multiple analytical platforms and sample types, aligned with the 2024 Alzheimer’s Association diagnostic framework, which emphasizes biomarker-driven AT(N) categories:

  • Amyloid pathology (A)
  • Tau pathology (T)
  • Neurodegeneration (N) 

This integrated approach enables harmonised biomarker strategies from early research through late-phase clinical development. 

Blood-based biomarker testing

Fujirebio Lumipulse® G pTau217/β-Amyloid 1–42 Plasma Ratio

  • FDA-cleared assay to aid identification of amyloid pathology associated with Alzheimer’s disease 
  • Intended for adults ≥50 years with signs of cognitive decline in specialised care settings 
  • Demonstrates strong agreement with amyloid PET and CSF reference standards 
  • Used as an adjunct to clinical evaluation (not a standalone or screening test)

Fujirebio Lumipulse® G pTau217 Plasma (EU)

  • CE-IVDR marked test supporting identification of amyloid pathology 
  • Intended for adults ≥50 years with cognitive symptoms 
  • Provides strong agreement with PET and CSF measures 

Roche Elecsys® Phospho-Tau (181P) Plasma

  • FDA- and CE-cleared IVDR blood-based assay 
  • Supports early assessment and rule-out of Alzheimer’s-related amyloid pathology 

Supporting neuromarker testing capabilities

Cerebrospinal Fluid (CSF) Biomarkers

CSF biomarkers remain well-established comparators in clinical research and are often used alongside imaging and plasma biomarkers: 

  • Total tau (tTau)
  • Phosphorylated tau (pTau181)
  • Amyloid beta 1–42 (Aβ42)
  • Key ratios: tTau/Aβ42, pTau181/Aβ42 

Genetic testing: APOE genotyping

The APO-Easy® Genotyping Kit is a PCR-based diagnostic test used to detect APOE genotypes associated with Alzheimer’s disease risk. 

  • Supports assessment of late-onset AD risk alongside clinical findings 
  • Not a standalone diagnostic or screening test 

Additional biomarker solutions

To support broader neurodegenerative research, ICON provides access to advanced and specialty testing, including:

  • Quanterix Simoa HD-X (ultrasensitive): GFAP, NfL 
  • ProteinSimple Ella®: GFAP, NfL, YKL-40, sTREM2 
  • MSD (Meso Scale Discovery): Multiplex neuroinflammation panels 
  • Referral testing: α-synuclein assays for synucleinopathies 

The ICON labs advantage

  • Global coverage: Harmonised network of accredited central labs across the US, Ireland, Singapore, and China 
  • Integrated testing approach: AT(N) biomarkers, genetic risk assessment, and specialty assays 
  • Regulatory-aligned solutions: Supporting Phase I–IV CNS drug development 
  • Scientific expertise: Custom assay development, method bridging, and biomarker strategy consultation 
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