The FDA has authorized the use of the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, marking the first blood-based test to assist in diagnosing Alzheimer’s disease.

By measuring levels of two proteins (pTau217 and β-amyloid 1-42), it helps identify amyloid plaque buildup, a key sign of Alzheimer’s.

Designed for individuals aged 55 and above with signs of cognitive decline, it offers a convenient alternative to PET scans and spinal taps.

Clinical trials demonstrated 91.7% sensitivity and 97.3% specificity.

Cleared under the 510(k) pathway and granted Breakthrough Device status, the test should be used alongside other clinical assessments, not as a standalone diagnostic method.