Milken Institute Calls for Wider Adoption of Alzheimer’s Blood Biomarker Testing
The report outlines the clinical, laboratory, reimbursement, and infrastructure changes needed to move blood-based Alzheimer’s biomarkers into routine patient care
Blood-based biomarker testing could significantly expand access to earlier and more accurate Alzheimer’s disease diagnosis, but healthcare systems will need to address reimbursement, laboratory capacity, clinical workflows, and provider education before the tests can become routine, according to a new Milken Institute report.
The July 21 report, Advancing Blood-Based Biomarkers for Alzheimer’s and Cognitive Care, examines how healthcare organizations can integrate blood-based biomarkers (BBMs) into cognitive care. The Milken Institute interviewed 32 experts, surveyed 22 stakeholders across six industry segments, reviewed existing literature, conducted a patient focus group, and evaluated healthcare-system readiness for adoption.
Advances in laboratory technology now allow blood samples to detect biomarkers associated with Alzheimer’s disease that previously required cerebrospinal fluid testing or positron emission tomography (PET) imaging. The Milken Institute noted that FDA-cleared BBMs could provide a more scalable, minimally invasive, and potentially less costly route to identifying Alzheimer’s pathology.
As reported by Today’s Clinical Lab, blood-based biomarkers such as phosphorylated tau are increasingly being evaluated as practical tools for Alzheimer’s diagnosis. These assays could offer a less invasive and more scalable alternative to PET imaging and cerebrospinal fluid testing while helping move biomarker testing into more routine clinical workflows.
Reimbursement is also beginning to catch up with the science. Dark Daily recently reported that Anthem Blue Cross and Blue Shield will begin covering certain blood-based Alzheimer’s biomarker tests under revised medical-necessity criteria, including eligible testing with C2N Diagnostics’ PrecivityAD2 beginning Oct. 1, 2026. The policy could help establish a clearer payment pathway for laboratories offering validated Alzheimer’s blood tests.
The regulatory landscape is advancing as well. In 2025, the US Food and Drug Administration cleared Fujirebio Diagnostics’ Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, the first blood test cleared to aid in diagnosing Alzheimer’s disease. That milestone helped accelerate interest in blood-based testing and supports the broader shift toward integrating Alzheimer’s biomarkers into routine laboratory medicine.
Laboratories could play larger role in Alzheimer’s diagnosis
For clinical laboratories, wider use of Alzheimer’s biomarkers could create a rapidly expanding testing category while increasing demands for standardized testing, clear performance criteria, appropriate interpretation, and integration of results into patient-care pathways.
The report identifies barriers to adoption and highlights health systems already incorporating BBMs into cognitive care. It also calls for coordinated action among laboratories, clinicians, payers, health systems, regulators, and patient organizations to establish the infrastructure needed for broader use.
Professor Fiona Carragher, chief policy and research officer at Alzheimer’s Society, has emphasized the potential impact of these tests on existing diagnostic pathways. “The blood biomarker challenge is about revolutionizing the diagnostic pathway. And the blood test is a key part of that,” Carragher said.
The issue is becoming increasingly important as disease-modifying Alzheimer’s therapies make timely and accurate diagnosis more consequential. Blood testing could also reduce reliance on more expensive or invasive diagnostic procedures while enabling more patients to receive confirmatory testing.
For medical laboratory leaders, the Milken Institute report provides another indication that Alzheimer’s diagnostics may be moving closer to mainstream laboratory medicine. If adoption accelerates, labs could become increasingly central to determining which patients receive additional evaluation and ultimately qualify for emerging treatments.
This article was created with the assistance of Generative AI and has undergone editorial review before publishing.
