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Roche granted FDA Breakthrough Device Designation for blood test to support earlier Alzheimer's disease diagnosis

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Roche granted FDA Breakthrough Device Designation for blood test to support earlier Alzheimer's disease diagnosis

Roche granted FDA Breakthrough Device Designation for blood test to support earlier Alzheimer's disease diagnosis

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  • The US FDA has granted breakthrough device designation to the company’s blood test, Elecsys pTau217 assay, for the diagnosis of Alzheimer's disease
  • Developed in partnership with Eli Lilly, the assay is intended to detect the presence or absence of amyloid pathology in individuals enabling appropriate treatment through participation in clinical evaluations or accessing approved disease-modifying therapies
  • The Elecsys Phospho-Tau (217P) is an in vitro immunoassay developed for the determining Phospho-Tau (217P) protein quantitatively among individuals of age 60yrs. & above and is intended to diagnose Alzheimer's disease

Ref: Roche | Image: Roche

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