FDA Approves First Blood Test for Early Alzheimer’s Diagnosis
For families facing Alzheimer’s disease, getting a clear diagnosis has often meant costly brain scans or an invasive spinal tap. It looks like those days are thankfully coming to an end, and the team at GeniusOfMarian.com wants to make everyone affected is aware of this exciting announcement.
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Many have waited in uncertainty, unsure what’s causing memory loss in a loved one. Now, the U.S. Food and Drug Administration has cleared the first blood test designed to help diagnose Alzheimer’s disease. This development promises a simpler, more accessible path to early detection - giving families answers sooner and opening doors to treatment and planning.
What Is the New Alzheimer’s Blood Test?
The test, known as Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio (“Lumipulse“ for short), measures two key proteins in the blood - beta-amyloid 1-42 and phosphorylated tau (pTau217) - and computes their ratio. This ratio closely matches the presence of amyloid plaques in the brain, a hallmark of Alzheimer’s disease.
Clinicians draw a standard blood sample and send it to a lab equipped with ultra-sensitive assays. Within days, a report indicates whether the protein levels suggest Alzheimer’s-related changes.
Why This Test Matters for Families
Early detection can change how families cope with an Alzheimer’s diagnosis. When a loved one begins to show memory problems, knowing the cause quickly can:
Allow access to treatments at a stage when they offer the most benefit.
Give families time to adjust living arrangements, plan finances, and discuss care wishes together.
Reduce stress by avoiding drawn-out testing or ongoing uncertainty.
Maria C. Carrillo, Ph.D., chief science officer at the Alzheimer’s Association, noted, “For too long Americans have struggled to get a simple and accurate diagnosis; with today’s action by the FDA we are hopeful it will be easier for more individuals to receive an accurate diagnosis earlier.” You can view the Association’s statement here.
Who Should Get the Test?
The Lumipulse blood test is cleared for adults 55 and older who are showing noticeable memory loss or cognitive decline. It is meant to fit into a doctor’s evaluation once other causes - like vitamin deficiencies or thyroid problems - are ruled out.
This test is not a general screening for people without symptoms. Instead, it helps specialists confirm whether Alzheimer’s is likely behind existing cognitive issues.
If your primary care doctor isn’t familiar with the test, ask for a referral to a memory clinic or neurologist for you or your loved one.
Accuracy and Limitations
In a clinical study involving 499 patients with memory concerns, the blood test showed:
91.7% positive agreement with PET scans or spinal-fluid tests
97.3% negative agreement in cases without amyloid plaques
These figures mean the test is highly reliable at indicating whether Alzheimer’s-related proteins are present. However, no test is perfect:
A small number of false positives could lead to unnecessary worry or treatment.
A small number of false negatives might delay a correct diagnosis.
Doctors will use the blood test alongside cognitive exams and imaging to complete the evaluation.
Next Steps After Testing
Once the blood test results arrive, your healthcare provider will help you understand what they mean and guide you through the following steps. These actions ensure that the diagnosis is as accurate as possible and that both patients and families have a clear plan in place.
Positive result
Order imaging (MRI or PET) to confirm and assess disease stage.
Discuss treatment options, including FDA-approved drugs and clinical trials.
Connect families with support services for care planning.
Negative result
Investigate other causes—such as vascular issues, Lewy body dementia, or mood disorders.
Avoid unneeded Alzheimer’s treatments.
Continue monitoring cognitive health with periodic check-ups.
Whether your result is positive or negative, it’s important to stay in close contact with your medical team. They can adjust your care plan as needed and help you access resources, from counseling to community support groups, to ease the path forward. This blood test is just one part of a larger process that keeps patients and their families informed and supported every step of the way.
Practical Considerations
Before scheduling the blood test, it helps to understand the real-world factors involved—so you and your family can prepare and avoid surprises. These practical details cover cost, coverage, and where to access the test once it’s available.
Cost: Estimated between $500 – $1,000, much lower than a PET scan.
Insurance: FDA clearance should lead Medicare and private insurers to cover the test.
Availability: Rolling out to major labs and memory clinics in summer 2025; ask your doctor or a memory specialist if they can order it.
If you’re interested in booking the test, start by checking with large national lab providers (such as LabCorp or Quest Diagnostics) and local hospital systems. Your neurologist or memory clinic should also have the latest information on where Lumipulse is being offered—so don’t hesitate to reach out and ask.
According to Alzheimer’s.net, “As blood tests become more common for Alzheimer’s markers, clinics will refine their pricing and insurance policies, making advanced diagnostics a standard part of memory care”.
A Milestone in Alzheimer’s Care
The FDA’s approval of Lumipulse marks a major advance in making Alzheimer’s diagnosis more straightforward. It does not cure the disease, but it removes significant hurdles in getting an early, accurate answer. This blood test could soon become as routine as checking cholesterol—helping families start treatment and planning sooner.
Rutgers University highlighted this shift in its July 18, 2025 news release. university researchers observed that moving Alzheimer’s diagnostics from specialized imaging centers into routine clinical labs represents a major shift in how memory disorders are identified. They noted that community physicians will soon have access to a tool once confined to large research hospitals, reducing wait times and widening the pool of patients who can benefit.
FAQ
Q: Is the blood test painful?
A: No - only a routine blood draw, with minimal discomfort.
Q: Can it predict Alzheimer’s before symptoms?
A: No - it’s intended for people already showing cognitive changes.
Q: Will my doctor know how to order it?
A: If not, request a referral to a memory clinic or neurologist familiar with the test.
GeniusofMarian.com celebrates this FDA-approved blood test as a watershed moment for families seeking clear answers about memory changes. Until now, many caregivers faced long waits, costly scans, or invasive procedures just to learn whether Alzheimer’s was at the root of a loved one’s symptoms.
With a simple blood draw, doctors can now gather critical information faster and in more places—community clinics, local hospitals, and even primary care settings. This shift means that families can begin important conversations about treatment, care needs, and future planning without months of uncertainty.