Regulation
Roche’s pTau217 single-biomarker Alzheimer’s blood test lands FDA approval
Roche's pTau217 blood test for Alzheimer's disease received FDA clearance, following CE mark approval in Europe in May 2026. The single-biomarker assay detects phosphorylated tau-217, a protein associated with Alzheimer's pathology, enabling blood-based diagnostic screening without requiring imaging or lumbar puncture.
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