FDA Clears First Blood Test to Help Diagnose Alzheimer Disease
The US Food and Drug Administration (FDA) has approved the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test, the first blood-based diagnostic tool intended to aid in evaluating Alzheimer disease (AD) pathology. Developed by Fujirebio Diagnostics, Inc., the test measures plasma levels of phosphorylated tau 217 and β-amyloid 1-42, generating a ratio associated with the presence of cerebral amyloid plaques, a hallmark of AD.
“Nearly 7 million Americans are living with Alzheimer disease. and this number is projected to rise to nearly 13 million,” said Center for Devices and Radiological Health Director Michelle Tarver, MD, PhD. Friday’s “clearance is an important step for Alzheimer disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease.”
Clearance was granted through the FDA’s 510(k) premarket notification pathway, demonstrating substantial equivalence to a previously authorized cerebrospinal fluid (CSF)-based test.
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The test is indicated for use in patients aged ≥55 years with signs and symptoms of cognitive impairment and is intended for evaluation in specialized care settings. It is not authorized for screening or use as a stand-alone diagnostic. The test offers a less invasive alternative to CSF sampling and amyloid Positron Emission Tomography (PET) imaging, both of which are commonly used but potentially less accessible.
FDA clearance was based on a multicenter clinical study of individual plasma samples from 499 cognitively impaired individuals. Among participants with Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio positive results, 91.7% had amyloid plaque presence confirmed by PET or CSF analysis; 97.3% had a negative amyloid PET scan or CSF test result. Fewer than 20% of cases yielded indeterminate results.
“The risks associated with the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio are mainly the possibility of false-positive and false-negative test results. False positive results, in conjunction with other clinical information, could lead to an inappropriate diagnosis of, and unnecessary treatment for, Alzheimer disease.” said the FDA news release. “This could lead to psychological distress, delay in receiving a correct diagnosis, as well as expense, and the risk for side effects from unnecessary treatment.”
Test results should be interpreted alongside clinical findings and other diagnostic workups.
No boxed warnings are associated with the device.
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