Plasma Immunoassay Panel for Alzheimer’s Disease
Validated Biomarker Solution for Neurodegenerative Research
Background
Alzheimer’s disease (AD) is marked by amyloid plaques, tau tangles, and neurodegeneration, causing progressive cognitive decline. Recent advances in blood-based biomarker technology enable earlier, more accessible, and less invasive detection, supporting broader inclusion in clinical trials and routine screening.
Navigate BioPharma Services, a Novartis subsidiary, offers a validated plasma biomarker panel designed to accelerate Alzheimer’s disease (AD) and neurodegenerative research. Our solution combines high sensitivity, precision, and operational efficiency using the Beckman Coulter DxI 9000™ platform.
Panel Highlights
- Phosphorylated tau 217 (p-Tau217): Strong diagnostic performance; correlates with amyloid pathology.
- Glial Fibrillary Acidic Protein (GFAP): Astrocytic marker; tracks amyloid pathology and predicts cognitive decline.
- Neurofilament Light Chain (NfL): Indicator of neuronal injury; correlates with axonal degeneration.
- Apolipoprotein E (APOE) ε4: Most significant genetic risk factor for late-onset AD.
- Amyloid beta 1-42 (Aβ1-42): Key component of amyloid plaques; central to AD pathogenesis.
Technical Overview
- Assay Type: Chemiluminescence
- Intended Use: Pharmacodynamic monitoring for exploratory endpoints in clinical trials
- Validation Level: Research Use Only (RUO)
- Sample Type: Human K2 EDTA plasma
Key Benefits/Clinical Utility
- Early Detection – Blood-based testing vs. invasive CSF/PET.
- Disease Differentiation – AD, PD, and MS insights.
- Trial Enablement – Robust precision for pharmacodynamic endpoints.
- Operational Efficiency – Automated workflow reduces cost and increases throughput.
Validation Summary
These fit-for-purpose immunoassays were validated per FDA Bioanalytical Method Validation and Clinical & Laboratory Standards Institute (CLSI) guidelines with the following key validation parameters:
Analyte | LoQ (pg/mL) | ULOQ (pg/mL) | Precision (%CV) | Accuracy (%Recovery) | Stability |
| AB42 | 0.69 | 170.60 | ≤13.8 | 73.8–92.5% | 4h RT; 3 FT |
| APOE ε4 ratio | N/A | N/A | ≤8.7 | N/A | 4h RT; 3 FT |
| GFAP | 0.3 | 572.2 | ≤2.8 | 96.4–111.8 | 4h RT; 3 FT |
| NfL | 6.2 | 9329 | ≤10.0 | 94.5–109.0 | 4h RT; 3 FT |
| pTau217 | 0.101 | 6.968 | ≤13.3 | 99.6–112.0 | 4h RT; 3 FT |
LoQ: Limit of quantitation; ULOQ; Upper limit of quantitation; N/A: Not applicable; FT: Freeze-Thaw; RT: Room temperature
References
- Wisch JK, Ances BM. Ruling in, ruling out: the clinical utility of plasma biomarkers in diagnosis of Alzheimer’s disease. J Clin Invest. 2025;135(19):e198725
- Ashton NJ, Brum WS, Di Molfetta G, et al. Diagnostic Accuracy of a Plasma Phosphorylated Tau 217 Immunoassay for Alzheimer Disease Pathology. JAMA Neurol. 2024;81(3).
- Dark HE, Duggan MR, Walker KA. Plasma biomarkers for Alzheimer’s and related dementias: A review and outlook for clinical neuropsychology. Arch Clin Neuropsychol. 2024;39(3):313–324.
- Pacoova Dal Maschio V, Roveta F, Bonino L, et al. The Role of Blood-Based Biomarkers in Transforming Alzheimer’s Disease Research and Clinical Management: A Review. Int J Mol Sci. 2025;26(17):8564.
- Alzheimer’s Association. Alzheimer’s Blood Test: p-tau217, Aβ42/40 & Biomarkers for Faster Diagnosis.
- Hansson O, Blennow K, Zetterberg H, Dage J. Blood biomarkers for Alzheimer’s disease in clinical practice and trials. Nature Aging. 2023.
- Valletta M, Briel N, Yuksekel I, et al. Fluid biomarkers for neurodegenerative diseases: a comprehensive update. Alzheimer’s Research & Therapy. 2025Wisch JK, Ances BM. Ruling in, ruling out: the clinical utility of plasma biomarkers in diagnosis of Alzheimer’s disease. J Clin Invest. 2025;135(19):e198725