Roche’s Elecsys pTau217 Assay to Diagnose Alzheimer's Disease Gains the US FDA’s Breakthrough Device Designation
Shots:
- 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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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
