Alzheimer’s Disease

Advanced Fluid Biomarker Testing for Earlier, More Confident Diagnosis

Alzheimer’s Disease

Advanced Fluid Biomarker Testing for Earlier, More Confident Diagnosis

Overview

Alzheimer’s disease (AD) is a progressive neurodegenerative disorder and the leading cause of dementia, accounting for 60% to 80% of cases1. The disease is defined biologically by the accumulation of β-amyloid plaques and tau neurofibrillary tangles, pathological changes that can begin fifteen to twenty years before the onset of clinical symptoms2,3.

Blood-based and CSF biomarker testing has moved from research settings into routine clinical practice. Plasma phospho-tau217 (pTau217) is now validated across more than a dozen independent immunoassay and mass-spectrometry platforms and is increasingly recognized as the front-line fluid marker for amyloid pathology9. Data presented at the 2026 Alzheimer’s Association International Conference (AAIC) further reinforce that multi-analyte reporting, combining pTau217 with markers such as Aβ42, GFAP, and neurofilament light (NfL), meaningfully reduces the proportion of diagnostically indeterminate results compared with any single analyte alone10.

CSF biomarker testing remains a well-validated alternative to amyloid PET imaging, with approximately 90% concordance between the two methods4, and real-world data presented at AAIC 2026 report comparable concordance, 91%, between blood-based biomarkers and CSF or amyloid PET in routine neurology practice11. Blood-based testing adoption is accelerating in parallel: 87% of physicians expect it to become the standard of care for AD evaluation6, and Medicare claims data presented at AAIC 2026 show confirmatory blood-based biomarker testing utilization more than doubling year over year12.

TrilliumBiO’s Alzheimer’s Disease Testing Portfolio gives clinicians a validated, CLIA-certified path to fluid biomarker testing, whether ordering the CSF panel or the full blood-based panel, supporting earlier, more confident diagnosis and more informed care planning.

7.4 Million Americans Age 65+ Are Living With Alzheimer’s Disease in 2026, Projected to Nearly Double by 2050
Physicians Estimate 1 in 5 Seniors (18%) May Have Undiagnosed AD
Globally, More Than 75% of People With Dementia Have Not Received a Formal Diagnosis
Nearly 4 in 5 Americans (79%) Want to Know if They Have Alzheimer’s Disease Before It Impacts Their Lives
87% of Physicians Expect Blood-Based Testing to Become the Standard of Care

Clinical Utility

Enhanced Diagnostic Confidence

    • Plasma pTau217 is now validated across 15 or more independent platforms and, interpreted alongside clinical presentation and cognitive testing, supports earlier and more confident identification of AD pathology9.
    • CSF biomarker testing (Aβ42, pTau181, tTau) shows approximately 90% concordance with amyloid PET,4 and real-world blood-based biomarker data presented at AAIC 2026 report comparable concordance in routine neurology practice11.

Differentiation From Other Causes of Cognitive Decline

  • Multi-analyte panels combining pTau217 with GFAP and NfL help differentiate AD from vascular cognitive impairment, Parkinson’s disease, and other non-AD dementias13.
  • A 2026 multicenter real-world study spanning 38 memory clinics (n=1,443) found plasma pTau217 remained a stable, reliable differentiator of AD versus non-AD neurologic disorders13.

Insight Into Disease Burden and Progression

  • Multi-analyte reporting reduces the proportion of diagnostically indeterminate results compared with any single fluid marker, sharpening the clinical picture in early or borderline presentations10.
  • Plasma NfL has emerged as a strong predictor of progression to non-AD dementias among patients presenting with mild cognitive impairment, supporting its inclusion in a comprehensive blood-based panel14.

Support for Longitudinal Assessment and Treatment Monitoring

  • As anti-amyloid therapies become more widely used, GFAP and pTau species offer a fluid-based way to track biological response over time, complementing clinical and cognitive follow-up15.
  • Serial blood-based biomarker measurement may help clinicians monitor disease trajectory and therapy response without repeat CSF collection or PET imaging15.

Alzheimer’s Disease Testing Portfolio

CSF Biomarkers

Aβ42: amyloid plaque burden, the earliest core AD pathology, seen as a drop in CSF concentration as amyloid gets sequestered into plaques
pTau181: amyloid-driven tau phosphorylation
tTau: overall intensity of neuronal injury, a general severity signal

Blood-Based Biomarkers

*Aβ42: amyloid plaque burden
APOE4: genetic risk, the strongest common genetic risk factor for late-onset AD, useful for pretest probability rather than active pathology
**GFAP: reactive astrogliosis, an early neuroinflammatory response that rises with amyloid, often before tau spreads
**NfL: general axonal injury, non-specific, best used to track progression or flag non-AD causes of decline
pTau181: amyloid-driven tau phosphorylation
*pTau217: amyloid pathology, currently the single most sensitive and specific plasma marker and the front-line screening analyte
*tTau: overall neurodegeneration severity, less specific to AD than the phosphorylated tau species

*These biomarkers were developed and their performance characteristics determined by TrilliumBiO. They have not been cleared or approved by the U.S. Food and Drug Administration.

**For Research Use Only

Understanding Alzheimer’s Disease — Key Research

Mobile phlebotomy service

Mobile Phlebotomy Service:

If a blood draw is not possible in your office, you can utilize a mobile phlebotomy service, coordinated by TrilliumBiO, so patients can have their blood drawn at home, at their convenience. For more information, contact support@trilliumbio.com or call 1-888-261-2812, option 1.

Provider Test Kit Request Form

All fields required unless otherwise noted.
The NPI number of the authorizing physician is required to order the test.
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Your Order

Please choose the kit(s) and select the quantity you would like to order. Clinical testing is not yet offered in New York State, research use only.
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Agreement Review

Testing is performed by TrilliumBiO, a CLIA-certified, CAP-accredited, ISO 15189-accredited clinical laboratory. Use of these tests and their results should not replace independent clinical judgment. The healthcare professional, in consultation with the patient, should consider all potential management options.

1. World Health Organization. Dementia. Accessed July 28, 2026. https://www.who.int/news-room/fact-sheets/detail/dementia 2. Jack CR Jr, et al. Lancet Neurol. 2010;9(1):119-128. doi:10.1016/S1474-4422(09)70299-6 3. Jack CR Jr, et al. NIA-AA Research Framework: Toward a Biological Definition of Alzheimer’s Disease. Alzheimer’s Dementia. 2018;14(4):535-562. doi:10.1016/j.jalz.2018.02.018 4. Rabinovici GD, et al. JAMA. 2019;321(13):1286-1294. doi:10.1001/jama.2019.2000 5. Cognat E, et al. BMJ Open. 2019;9(5): e026380. doi:10.1136/bmjopen-2018-026380 6. Quest Diagnostics. The Coming Alzheimer’s Disease Healthcare Revolution: US Physician and Adult Perspectives on the Future of Diagnostics and Treatment. May 2022 7. Alzheimer’s Association. 2026 Alzheimer’s Disease Facts and Figures. Alzheimer’s Dementia. 2026. Accessed July 2026 8. Baylor College of Medicine. The ethics of telling an Alzheimer’s diagnosis and the power of communication. April 2025 9. Chun MY, et al. Cognitive Stage–Adapted Amyloid PET Thresholds for Plasma p-tau217 Testing. AAIC 2026; July 12–15, 2026; London, UK 10. Wilson D, et al. Multi-Analyte Plasma Risk Score Improves Sensitivity and Certainty for Early AD Detection in a Diverse Community-Based Cohort. AAIC 2026; July 12–15, 2026; London, UK 11. Chabrashvili T, Qasim S. Real-World Concordance of Blood-Based Biomarkers with CSF or PET in Suspected Alzheimer’s Disease. AAIC 2026; July 12–15, 2026; London, UK 12. Nair K, et al. Blood-Based Biomarkers in Early Alzheimer’s Disease: Real-World Adoption Trends and the Transformation of Diagnostic Pathways. AAIC 2026; July 12–15, 2026; London, UK 13. Li C, et al. Real-world Diagnostic Performance of Plasma P-tau217 in Memory Clinics: A Multicenter Study From Northwest China. AAIC 2026; July 12–15, 2026; London, UK 14. Giuffrè GM, et al. Real-world Diagnostic and Prognostic Performance of Plasma Biomarkers for Alzheimer’s Disease in a Mild Cognitive Impairment Cohort. AAIC 2026; July 12–15, 2026; London, UK 15. Lai Y, et al. Cognitive Function and Plasma Biomarkers Dynamics in Alzheimer’s Disease During Lecanemab Treatment: A Real-World Clinical Study. AAIC 2026; July 12–15, 2026; London, UK 16. Burns JM, et al. JAMA Neurology. 2026;83(6):515. DOI: 10.1001/jamaneurol.2026.0801