FDA-Cleared Blood-Based Alzheimer Disease Biomarker (Lumipulse pTau217 / Aβ42 Ratio, May 2025) Is a Specialist-Setting Aid in Symptomatic Adults 55+, NOT Population Screening

A blood-based Alzheimer disease biomarker received FDA clearance in May 2025 as a specialist-setting decision aid for symptomatic adults aged 55 and older; the test is not cleared for population screening, not cleared as a stand-alone diagnostic, and not cleared for asymptomatic

Type

evidence-claim

Domain

h04_loss_of_proteostasis

Grade

A

License

CC BY-NC 4.0

card_id

L-024

hallmarks

h04_loss_of_proteostasis

cluster

clinical_translation

primary_disease_area

alzheimers

evidence_tier

A

evidence_anchor_count

5

intake_round

R23

intake_date

2026-05-26

related_experts

related_biomarkers

bm_ptau217_ratio

related_interventions

related_trials

collection_pages

/research/biomarkers/blood-based-ad,/research/clinical-translation/diagnostic-clearance

LongProof Longevity Dynamic · LIGHT HOPE / x1000.ai · longevity.x1000.ai · 2026 · source

Read-only aggregated view. Longevity Evidence is the source of record; this catalog shows provenance as-is — no ratings, no reviews.