Validated plasma biomarkers for Alzheimer's disease — aligned with NIA-AA 2024 criteria
Alzheimer's disease is the most common cause of dementia, affecting over 55 million people worldwide. Diagnosis historically required invasive CSF testing or expensive amyloid PET scans. Our plasma biomarker panel now enables accurate, non-invasive blood-based detection of AD pathology, aligned with the 2024 NIA-AA revised diagnostic criteria (Jack et al., Alzheimer's & Dementia, 2024; DOI: 10.1002/alz.13859).
Adults aged ≥50 with mild cognitive impairment (MCI) or symptoms of dementia undergoing evaluation for Alzheimer's disease. Clinicians initiating anti-amyloid therapy (lecanemab, donanemab) who require biomarker confirmation per prescribing guidelines. Research and clinical trial eligibility screening.
Not for asymptomatic population screening. Not a standalone diagnostic — results require clinical interpretation by a specialist (geriatrician, neurologist, or geriatric psychiatrist). Not validated in individuals under 50.
| Step / Test | Accuracy | Notes |
|---|---|---|
| APOE genotyping sensitivity/specificity | 99.9% | * Genotyping accuracy of sequencing results. Passed GenQA/UK NEQAS |
| p-tau217 sensitivity | 94.6% | Wang, X., et.al. (2024). Alzheimer's Research & Therapy, 16(1), 82. |
| p-tau217 specificity | 91.9% | Wang, X., et.al. (2024). Alzheimer's Research & Therapy, 16(1), 82. |
| Aβ42/40 sensitivity | 84.0% | Schindler, S. E., et.al. (2019). Neurology, 93(17), e1647-e1659. |
| Aβ42/40 specificity | 81.8% | Schindler, S. E., et.al. (2019). Neurology, 93(17), e1647-e1659. |
10mL Whole Blood in EDTA (APOE); 4mL Blood Plasma
10 mL peripheral blood in EDTA (purple-top) tube. Collected by a licensed healthcare professional.
Samples must be collected and submitted by a licensed healthcare professional.
Results reported as continuous quantitative values with interpretive comments relative to published cut-offs. Interpretation requires clinical context and specialist review.
Plasma p-tau217 is reported as the primary AD biomarkers (NIA-AA 2024 Core Tier 1). Results are categorised as positive/intermediate/negative relative to validated amyloid PET concordance cut-offs. ApoE gene provides insight into inherited risk of late‑onset Alzheimer’s disease. Results identify ApoE type (ε2, ε3, or ε4) and explain whether the genetic risk may be lower, average, or higher than the general population.
The 2024 NIA-AA revised criteria (Jack et al., Alzheimer's & Dementia 2024) established plasma biomarkers as the primary diagnostic tool for AD, replacing the requirement for invasive CSF or PET imaging in most clinical settings. The criteria define Core Biomarker tiers: p-tau217 and Aβ42/40 are Tier 1 (highest specificity for amyloid and tau pathology); p-tau181 is Tier 2. GFAP and NfL are non-specific neurodegeneration markers. APOE genotyping stratifies genetic risk. Our panel covers all major NIA-AA 2024 biomarker categories.
— Jack Jr, C.R. et al. Alzheimer's & Dementia, 20(8), 2024.Non-invasive blood biomarker tests such as plasma p-tau217 are now included in clinical guidelines.