FDA clears PrecivityAD2 blood test for Alzheimer's diagnosis

The U.S. Food and Drug Administration (FDA) has cleared PrecivityAD2, an innovative blood test designed to aid in the early diagnosis of Alzheimer's disease. Developed by C2N Diagnostics, the test identifies the presence of amyloid plaques in the brain, a key indicator of the disease.

Unlike other blood-based tests that utilize immunoassay methods, PrecivityAD2 employs high-resolution mass spectrometry to provide quantitative measurements of biomarkers. This approach offers a less invasive alternative to traditional cerebrospinal fluid testing, potentially allowing clinicians to evaluate patients more efficiently.

Early detection is critical for managing the disease, as recent treatments capable of slowing Alzheimer's progression are most effective when administered early in the diagnostic process. The underlying technology was originally developed by researchers at the Washington University School of Medicine in St. Louis.