CNS & neurology laboratory testing

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