FDA clears blood test to aid evaluation for Alzheimer's disease

The U.S. Food and Drug Administration (FDA) has approved an innovative blood test called PrecivityAD2 for marketing purposes. Developed at Washington University School of Medicine in St. Louis, the test aims to aid in the early diagnosis of Alzheimer's disease. PrecivityAD2 analyzes amyloid plaques in the brain, which are indicative of the disease.

Unlike other blood-based tests that rely on immunoassay methods, PrecivityAD2 uses high-resolution mass spectrometry to provide quantitative measurements of essential biomarkers. This allows for more accurate and reliable detection of amyloid plaques associated with Alzheimer's disease.

Early detection of Alzheimer's disease is crucial as new treatments can slow its progression when initiated early. The FDA clearance of PrecivityAD2 enables broader clinical use, increasing early and accurate diagnoses. This can lead to earlier treatment initiation, when drugs are most effective.

The test provides a less invasive alternative to cerebrospinal fluid testing, which can be uncomfortable and time-consuming. Biomarker information obtained from PrecivityAD2 can also help inform appropriate clinical management when combined with a patient's clinical history and other diagnostic data.

The underlying technology for PrecivityAD2 was initially developed by a Washington University team led by Randall J. Bateman, MD, and David M. Holtzman, MD. C2N Diagnostics, a WashU startup co-founded by Bateman, Holtzman, and others in 2007, obtained exclusive commercial license rights to the patented technologies. They optimized and commercialized the assays that form the basis of the test.