A Drop of Blood to Detect Alzheimer’s: FDA Approves the First Blood Test for Diagnosis
By: Alejandra Legarda | Special to Al Día News

In a significant breakthrough for the early detection of Alzheimer’s disease, the U.S. Food and Drug Administration (FDA) has approved the first blood test designed to aid in diagnosing this neurodegenerative condition. The test, known as Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, was developed by Fujirebio Diagnostics and offers a less invasive, more accessible alternative to traditional methods like PET scans or spinal taps.

The Lumipulse test measures plasma levels of two key proteins associated with Alzheimer’s: beta-amyloid 1-42 and phosphorylated tau 217. The ratio between these proteins helps detect the presence of amyloid plaques in the brain, a hallmark of the disease. The test is intended for adults aged 55 and older who are experiencing symptoms of cognitive decline. In clinical studies, it demonstrated 91.7% accuracy in detecting amyloid plaques and 97.3% in confirming their absence, compared to PET scans or cerebrospinal fluid analysis.

Nearly 7 million Americans currently live with Alzheimer’s, and this number is expected to double by 2050, according to statistics. The approval of this test marks a crucial step toward earlier and more accessible diagnoses.

The introduction of this blood-based test could revolutionize the way Alzheimer’s is diagnosed, allowing the disease to be identified in earlier stages and improving access to treatments that may help slow its progression. However, experts caution that the test should not be used as a standalone diagnostic tool. While valuable, its results should be interpreted alongside thorough clinical assessments.

It is also important to emphasize that the Lumipulse test is not designed for preventive screening in asymptomatic individuals, due to the risk of false positives or negatives. Its use is recommended in specialized clinical settings, where healthcare professionals can incorporate its findings within a broader diagnostic framework.

With this approval, the FDA paves the way for a new era in Alzheimer’s detection, offering hope to millions of individuals and families facing the challenges of this disease.