The FDA has just recently approved a new blood test called The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, that helps with the early detection of Alzheimer’s diseases in older populations aged 55 years or older who experience symptoms of the disease.
Alzheimer’s affects more people than breast and prostate cancer combined,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “With 10% of those over 65 currently living with the disease—and that number projected to double by 2050.
Alzheimer’s disease is a progressive brain disorder that gradually impairs memory, thinking, and daily function, typically appearing later in life. A key feature is the buildup of amyloid plaques in the brain, which can help doctors determine the likely cause of symptoms. These plaques are usually detected through amyloid PET scans an effective but expensive, time-consuming method that involves radiation exposure.
The Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test measures two proteins in the blood to calculate a ratio linked to the presence of brain amyloid plaques, reducing the need for PET scans. Unlike earlier tests using spinal fluid from invasive lumbar punctures, this new test only requires a simple blood draw, making it easier and less invasive for patients.
The clinical study preformed involved 499 individual plasma samples from adults who were cognitively impaired where their Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio test results was compared to amyloid PET scan or CSF test results. Results revealed that 91.7% of patients with a positive Lumipulse test had confirmed amyloid plaques, while 97.3% with a negative result showed no plaques. Fewer than 20% of the 499 participants received an indeterminate result.
The Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test has shown strong reliability in identifying the presence or absence of amyloid pathology linked to Alzheimer’s in cognitively impaired patients. It is intended for use in specialized care settings and should be interpreted alongside other clinical information. While the test offers a less invasive diagnostic option, there are risks of false positives or negatives. A false positive could lead to misdiagnosis, unnecessary treatment, and emotional or financial strain, while a false negative may delay proper diagnosis and care. This test is not meant for general screening or to be used on its own for diagnosis; further clinical evaluation is essential to guide treatment decisions.
Finally, The FDA granted Breakthrough Device designation and clearance for the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio to Fujirebio Diagnostics, Inc., recognizing its potential to improve diagnosis of serious life-threatening or irreversibly debilitating conditions.
Learn more: FDA Clears First Blood Test Used in Diagnosing Alzheimer’s Disease | FDA