- The FDA cleared Lumipulse, a blood test by Fujirebio Diagnostics, which detects amyloid beta plaques – a key Alzheimer’s marker – by measuring proteins p-Tau217 and beta-amyloid 1-42. This offers a faster, cheaper and more accessible alternative to PET scans or spinal taps.
- Current methods (PET scans and spinal taps) are costly and invasive, often delaying diagnosis. Lumipulse’s simple blood draw could make early detection feasible for millions, especially as Alzheimer’s cases are projected to double by 2050.
- Clinical trials showed 91.7 percent accuracy in aligning with positive PET/spinal tap results and 97.3 percent accuracy in ruling out amyloid buildup. However, false positives/negatives remain possible, requiring supplemental clinical evaluation.
- Early detection could help identify candidates for new drugs like Leqembi and Kisunla, though these treatments face skepticism due to high costs, limited efficacy, and serious side effects.
- While Lumipulse marks progress, debates persist about amyloid’s role in Alzheimer’s and the need for better therapies. Competing blood tests are in development, signaling a shift toward more accessible diagnostics – but clearer guidelines and more effective treatments are still needed.
(Natural News)—For decades, diagnosing Alzheimer’s disease has been an expensive, invasive and often inaccessible process. But a blood test approved the Food and Drug Administration (FDA) changes that.
On May 16, the FDA cleared the first-ever blood test designed to detect signs of Alzheimer’s. Developed by Fujirebio Diagnostics, the test – branded as Lumipulse – measures two key proteins in the blood to identify amyloid beta plaques, a hallmark of the neurodegenerative disease.
bet insurance companies will like to see the results