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

The U.S. Food and Drug Administration (FDA) has granted approval for marketing an innovative blood test called PrecivityAD2, which was developed using technology originally invented at Washington University School of Medicine in St. Louis. C2N Diagnostics, a startup company born from WashU Medicine, created and validated this blood-based diagnostic test.

PrecivityAD2 aids in identifying amyloid plaques, a hallmark of Alzheimer's disease, in certain patients by analyzing blood for specific biomarkers associated with the condition. Unlike other blood tests that use immunoassay methods, PrecivityAD2 employs high-resolution mass spectrometry to deliver precise measurements of these biomarkers.

This advancement could help clinicians diagnose Alzheimer's disease using a less invasive method than spinal taps or brain scans, especially for patients presenting mild symptoms. Early detection is crucial as recent treatments can effectively slow the progression of the neurodegenerative disease when administered promptly. The test's FDA clearance ensures it matches the accuracy of more invasive diagnostic tests, potentially increasing early and accurate diagnoses and enabling patients to receive treatment sooner.

Bateman and Holtzman, co-leaders of the foundational research, initiated C2N Diagnostics in 2007 to commercialize this technology. With FDA clearance, the test can reach a broader range of clinicians and health systems, and insurance may eventually cover the cost, making it more accessible to patients.