FDA clears new biomarker assays for early Alzheimer’s detection
Roche has received US Food and Drug Administration 510 clearance for additional cerebrospinal fluid assays for Alzheimer’s disease , supporting timely diagnosis and treatment decision-making.
They join the Elecsys beta-amyloid CSF II and Elecsys phospho-tau CSF assays that received FDA 510 clearance in 2022,"An early and accurate diagnosis can help patients, caregivers and physicians determine a path forward, and the Elecsys CSF assays support diagnosis at early disease stages, when treatment is most effective," Brad Moore, president and CEO of Roche Diagnostics North America, said in a statement.
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