Roche’ Elecsys pTau181 Test Receives the European CE Mark Approval to Rule Out Alzheimer’s Disease
Shots:
- Roche has received the CE mark approval for its Elecsys pTau181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology
- Approval was backed by a global study of 787 pts (55–80yrs.) across the US, EU, & Australia, showing 93.8% negative predictive value (NPV) based on a 22.5% prevalence of amyloid positivity per PET scans & 83.6% sensitivity in ruling out Alzheimer’s, with minimal impact from age, gender, BMI, or kidney function
- Elecsys pTau217 is an in-vitro diagnostic test that quantifies Phospho-Tau (217P) in plasma to help identify amyloid pathology, with data showing high accuracy & greater stability than the pTau217/Aβ42 ratio at room & refrigerator temperatures
Ref: GlobeNewsWire| Image: Roche| Press Release
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