The FDA has cleared PrecivityAD2, a blood test intended to help evaluate Alzheimer’s disease by detecting Alzheimer’s-linked amyloid pathology. Developed from technology pioneered at Washington University School of Medicine in St. Louis, the test was validated to support clinical decision-making as an aid—not a standalone diagnosis. For biotech, the clearance adds momentum to plasma-based biomarker strategies that aim to simplify identification of amyloid-positive patients earlier in care pathways. It also increases competitive pressure among developers of blood assays targeting neurodegenerative disease biology. Clinically, cleared blood diagnostics are expected to improve access compared with imaging and cerebrospinal fluid workflows. The key near-term question will be how clinicians integrate PrecivityAD2 results into treatment selection and downstream confirmatory testing.