A Historic Milestone in Alzheimer’s Diagnosis –
Hope in a Simple Blood Test

A Long-Awaited Breakthrough for Patients and Families

The FDA has cleared the first-ever blood test to support Alzheimer’s diagnosis — marking a significant shift in how we detect and address the disease.

Developed by Fujirebio Diagnostics, Inc., the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test identifies abnormal proteins in the blood that are strongly associated to Alzheimer’s disease in the brain.

Why this matters:

For decades, definitive Alzheimer’s diagnoses were out of reach — often requiring expensive and invasive procedures such as spinal taps or PET scans. Now, with a simple blood draw costing just a few hundred dollars, physicians can more easily identify signs of Alzheimer’s and bring relief to families searching for answers.

*Note: This blood test is not a standalone diagnosis or cure. It is intended for older adults already showing symptoms of cognitive decline and should be used alongside clinical evaluations.

What this breakthrough means:

  • Clarity and Validation:
    While other blood tests exist, this is the first to receive FDA clearance, validating its accuracy and helping pave the way for wider clinical adoption, insurance coverage, and standardized integration into care.

  • Earlier Treatment and Brain Health Interventions:
    New therapies can slow Alzheimer’s progression, but only when given early. Blood tests enable timely diagnosis, increasing access to treatment while patients still have options and agency.

  • Easier Access to Clinical Trials:
    Faster identification of eligible clinical trial participants means faster progress in finding treatments—while ensuring more inclusive and representative research.

  • Time to Prepare:
    An early diagnosis allows families to plan ahead, explore care options, and access support while the person with Alzheimer’s can still participate in decisions.

Ensuring equitable access:

While Medicare currently covers the test, a national payment rate is still pending. Commercial insurers have yet to establish coverage, creating uncertainty.

Voices of Alzheimer’s is calling on:

  • Manufacturers to price the test transparently

  • Insurers to offer coverage

  • Providers to ensure widespread and equitable access

From Approval to Impact: What Needs to Happen Next

FDA clearance is only the first step. For this innovation to truly transform lives:

  • Providers Must Adopt It
    Physicians — across primary and specialty care — must be empowered with training and tools to offer the test effectively.

  • Insurers Must Cover It
    No patient should be denied answers due to financial barriers.

  • Patients Must Hear About It
    Raising awareness is essential to ensure those affected by cognitive decline can ask their doctors about this option.