FDA clears first blood-based diagnostic test for Alzheimer’s disease

Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio

© Fujirebio Diagnostics

The U.S. Food and Drug Administration (FDA) has cleared the first blood-based diagnostic that helps physicians determine whether cognitive-impaired patients carry the amyloid plaques that signal Alzheimer’s disease, the agency announced Friday.

The Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test from Fujirebio Diagnostics, Inc., measures two proteins in plasma and calculates their ratio, providing an indicator of amyloid pathology in adults 55 and older who show signs of dementia. The decision gives clinicians a less-invasive, more widely accessible alternative to amyloid PET scans or cerebrospinal fluid taps, both costlier and more burdensome procedures.

FDA officials hailed the clearance as a chance for early detection for a debilitating disease with rising patient counts.

“Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “Knowing that 10% of people aged 65 and older have Alzheimer's, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.”

How FDA clearance was obtained

Clearance relied on data from a 499-patient, multicenter trial of cognitively impaired adults. The blood test correctly identified amyloid plaque in 91.7% of patients who were positive by PET scan or cerebrospinal fluid testing and correctly ruled it out in 97.3% of patients whose imaging or CSF results were negative. Fewer than one in five samples produced indeterminate readings.

“Nearly 7 million Americans are living with Alzheimer's disease and this number is projected to rise to nearly 13 million,” said FDA Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D, in the news release. “Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease.”

Fujirebio Diagnostics’ President and CEO Monte Wiltse said physicians currently lack effective, accessible and noninvasive diagnostics for Alzheimers, and the test offers a solution for early detection. “As part of our worldwide commitment to improve the diagnosis and treatment of [Alzheimer’s disease], Fujirebio is developing additional assays, which will increase the availability of diagnostic tools and expand the foundation for early, more effective treatment.”

Indication and limitations

The assay is intended for specialty-care settings as an adjunct to other clinical evaluations; it is not authorized as a population screening tool. The FDA warned that false positives could lead to unnecessary treatments and psychological harm, while false negatives could delay appropriate therapy. Physicians must interpret results alongside a full clinical work-up.

Lumipulse was cleared through the 510(k) process as substantially equivalent to the company’s earlier CSF-based β-amyloid ratio test. The new assay also carried FDA Breakthrough Device status, which streamlines reviews for diagnostics addressing life-threatening or irreversibly debilitating condition.

Blood biomarkers have been a key goal for Alzheimer’s diagnostics developers because they could broaden access to early diagnosis, enrollment in clinical trials and timely initiation of disease-modifying therapies. Analysts expect the category to expand as payers look for lower-cost triage tools and as new treatments such as lecanemab and donanemab reach the clinic.

Fujirebio said it will launch the test for use on its Lumipulse G laboratory platform, already installed in major U.S. reference labs. Laboratories must validate the assay before offering it clinically. Pricing and reimbursement details were not disclosed.

For device makers, the clearance underscores the FDA’s willingness to use traditional pathways, supplemented by Breakthrough Device incentives, to speed innovations that fit into existing lab infrastructure and address urgent public-health burdens.

The burden of Alzheimer's disease

An estimated 7.2 million Americans age 65 and older are living with Alzheimer’s dementia in 2025, and when roughly 200,000 younger-onset cases (age 30-64) are included, the national patient pool surpasses 7.4 million, according to the Alzheimer's Association. That equates to about 1 in 9 U.S. seniors (11 percent), with women making up nearly two-thirds of those affected.

Absent disease-modifying breakthroughs, the Alzheimer’s Association projects the U.S. burden will climb to almost 13 million by 2050, underscoring the urgency for earlier detection and effective therapies.

While there is no single, stand-alone test to diagnose Alzheimer’s disease today, including this test, blood testing can be an important piece of the diagnostic process, said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer and medical affairs lead.

“Today marks another important step in Alzheimer’s disease diagnosis,” Carillo said in a news release. “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.”

About Fujirebio

Fujirebio Diagnostics, Inc. is a cancer diagnostics company and industry leader in cancer biomarker assays. The company pioneered and introduced the CA125 test, the first FDA-approved ovarian cancer biomarker, more than 25 years ago. Fujirebio Diagnostics specializes in the clinical development, manufacturing and commercialization of in-vitro diagnostic products for the management of human disease states, with an emphasis in oncology.