The evolution of blood-based biomarker testing represents a pivotal advancement in early Alzheimer’s disease detection, offering clinicians accessible tools for both triage and confirmatory pathology without immediate reliance on cerebrospinal fluid analysis or amyloid PET imaging.1 The first blood biomarker test to diagnose Alzheimer’s disease, the Lumipulse G blood test, was FDA-cleared in 2025.2,3 Plasma assays measuring the p-Tau217 and B-Amyloid 1-42 plasma ratio correlate to amyloid plaque presence in the brain, reducing the need for PET scan.3 This non-invasive testing enables clinicians to identify amyloid pathology in patients presenting with mild cognitive impairment or early dementia.3,4
Integration of these assays into clinical workflows aids in addressing the critical challenge of increasing screening in primary care with timely referral to specialists. By providing objective biomarker data earlier in the diagnostic process, neurologists can expedite confirmation of Alzheimer’s pathology and initiate appropriate management strategies while patients maintain functional independence. This is particularly valuable for individuals in the mild cognitive impairment (MCI) stage, where disease-modifying interventions may offer maximum benefit by slowing progression before significant functional decline occurs.5
The prognostic value of plasma biomarkers extends beyond diagnosis. Elevated p-tau217 levels are intimately linked with disease trajectory, informing discussions about disease progression and treatment timing. For researchers, p-tau217 may offer potential as a surrogate outcome measure in future clinical trials.4 For patients demonstrating biomarker evidence of amyloid pathology, early intervention with amyloid-targeting therapies becomes a consideration, potentially preserving cognitive function and delaying milestones such as loss of instrumental activities of daily living.1,4
Despite FDA clearance and emerging commercial availability of testing, implementation challenges persist, including insurance coverage variability and the need for established clinical pathways following positive results.6 However, as reimbursement expands and professional guidelines incorporate these tools, blood-based biomarkers will likely become standard practice and improve access to timely intervention for patients across the care continuum.1 Clinicians who adopt these assays now position themselves to deliver more timely, evidence-based care while reducing the diagnostic challenges that often delays appropriate treatment. The goal remains clear: identify pathology early, intervene appropriately, and maximize the window during which patients retain independence and quality of life.
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