Roche receives FDA clearance for Elecsys® pTau217, advancing Alzheimer's disease ...

Roche has received FDA clearance for Elecsys pTau217, the first and only FDA-cleared single-biomarker blood test that supports both rule-in and rule-out assessment of amyloid pathology related to Alzheimer's disease across primary and specialty care in the U.S. The test leverages Roche's existing U.S. lab infrastructure, enabling broad clinical adoption to aid earlier and easier diagnosis.

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