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A cutting-edge diagnostic test is transforming how Alzheimer’s disease is detected, and part of the research behind its approval was conducted by leading experts in ���ӽ紫ý’s Pam Quirk Biomarker Laboratory in the Chambers-Grundy Center for Transformative Neuroscience.

The test, called Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio, is an in vitro diagnostic (IVD) developed by , a company specializing in healthcare diagnostic tests.

���ӽ紫ý brain health researchers Dr. Jefferson Kinney and Dr. Jeffrey Cummings contributed one of the datasets from samples collected in Las Vegas that was part of the submission, which was officially approved by the U.S. Food and Drug Administration (FDA) in May.

The test is the first FDA-cleared blood-based IVD in the U.S. to aid in identifying patients with amyloid pathology associated with Alzheimer’s disease.

“The approval of this blood test is groundbreaking for Alzheimer’s disease in both research and treatment,” said Kinney, professor and founding chair of the Department of Brain Health at the Kirk Kerkorian School of Medicine at ���ӽ紫ý. “One of the largest hurdles in Alzheimer’s care is detection, and this test makes it possible to screen thousands of patients at scale — something that was never feasible with other approaches, all of which are far slower and far more expensive, like PET scans.”

Blood-based testing represents a major leap forward, Kinney says. This test could be used to detect Alzheimer’s earlier and more efficiently, potentially transforming how the disease is diagnosed and treated.

From Lab Samples to Development

Biomarkers – blood tests, brain scans, and other digital tools – are increasingly being used to diagnose and monitor Alzheimer's disease. Kinney’s research team has built a robust biobank and biomarker research effort over the past several years that has been noted for its broad capabilities and number of research projects, grants, and collaborations. 

The diagnostic company had already developed the instrument to test blood samples but needed critical datasets to strengthen its application for FDA approval. This provided the ideal opportunity for the data collected at ���ӽ紫ý to be part of the FDA application.

“We are incredibly proud that data collected from our laboratory and the collaborative research effort in Las Vegas has been able to contribute to such a leap forward in Alzheimer's disease detection," Kinney said. "Our field has been striving for this advancement for many years and it has been remarkable to work with Fujirebio."

A Future of Early Detection

Alzheimer’s disease is typically detected many years into the disease progression, when fewer options for medical intervention remain. Kinney says the development of the Lumipulse diagnostic test offers a promising solution for broad and accurate testing as well as earlier detection of one of the most prevalent neurodegenerative diseases.

Now that the FDA has issued its approval, further experiments and research will be conducted to refine the test’s reliability and results, as well as to determine how much earlier the disease can be detected. 

The Quirk Laboratory is currently examining several biomarkers, including the Lumipulse® G pTau 217/β-Amyloid 1-42 targets.

The laboratory was able to add the Lumipulse to its arsenal of diagnostic instruments through philanthropic support. The work is part of a collaborative Center of Biomedical Research Excellence grant collaboration between the Cleveland Clinic Lou Ruvo Center for Brain Health and ���ӽ紫ý. 

“���ӽ紫ý researchers consistently produce high-quality findings that advance knowledge across many fields, including medicine,” said David Hatchett, vice president of the ���ӽ紫ý Division of Research. “Their work has helped elevate ���ӽ紫ý to Carnegie R1 status, reinforcing our reputation for excellence and strengthening our global impact. The research happening here is creating better healthcare outcomes for our society."