FDA cleared PrecivityAD2, a blood test intended to evaluate Alzheimer’s disease risk by detecting amyloid pathology. The test, developed with technology pioneered at Washington University School of Medicine in St. Louis, received authorization for marketing as an aid in clinical evaluation. The clearance is notable because it expands access to amyloid assessment beyond imaging and lumbar procedures, potentially reducing time-to-information in diagnostic pathways. In practice, clinicians may use the test to help stratify patients for further workup or treatment planning. For biotech and diagnostics developers, the move also reinforces continued regulatory momentum for blood-based biomarkers that target core Alzheimer’s pathology.
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