The U.S. Food and Drug Administration has cleared a blood test developed from technology invented at Washington University School of Medicine in St. Louis to aid in evaluating Alzheimer's disease. The test, called PrecivityAD2, was developed and validated by C2N Diagnostics, a WashU startup co-founded by neurologists Randall Bateman and David Holtzman.
PrecivityAD2 uses high-resolution mass spectrometry to measure the ratio of amyloid-beta 42 and 40 and two forms of tau protein (p-tau217 and total tau217) in blood. These biomarkers are associated with amyloid plaques, a characteristic feature of Alzheimer's pathology. Previous studies demonstrated the test can diagnose amyloid pathology with more than 90% accuracy, performing comparably to cerebrospinal fluid tests and brain scans even in patients with mild cognitive symptoms.
The clearance allows the test to be marketed more broadly to clinicians and health systems that rely on FDA review for quality assurance. It may also facilitate insurance coverage, making the test more affordable and accessible. Physicians have been able to order the test for patients with mild cognitive symptoms, but the FDA clearance expands its availability.
Early detection is important because the first treatments capable of slowing Alzheimer's progression recently became available, and these drugs are more effective when started sooner. The blood test offers a less invasive approach than lumbar punctures or amyloid PET scans for identifying the presence of brain amyloid plaques.
The underlying technology stems from foundational research by Bateman and Holtzman into Alzheimer's-related amyloid and tau proteins. Their work included pioneering stable isotope-linked kinetics (SILK) approaches for studying amyloid-beta production and clearance in the brain and cerebrospinal fluid, which contributed to the scientific basis for blood-based biomarker technologies.
C2N Diagnostics, founded in 2007, employs more than 120 researchers, physicians, and other professionals and is expanding its headquarters to St. Louis' Cortex Innovation District. The company acquired exclusive commercial license rights to patented technologies developed in the Bateman and Holtzman labs.
FDA clearance signifies the test has undergone rigorous evaluation confirming accuracy comparable to more invasive methods. The biomarker information is intended to be interpreted together with a patient's clinical history and other diagnostic information to inform appropriate clinical management.
FDA clears blood test to aid evaluation for Alzheimer's disease
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