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Roche

Roche’ Elecsys pTau217 Test Receives the US FDA Clearance to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

Shots: The US FDA has granted clearance to Elecsys pTau217 to measure the phosphorylated Tau (pTau) 217 protein to help rule in or rule out Alzheimer’s-related amyloid pathology in people (≥55yrs.) with signs or complaints of cognitive decline In adults aged 55+ with cognitive decline associated with Alzheimer’s disease, Elecsys pTau217 showed high agreement with…

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Roche

Roche’ Elecsys pTau217 Test Receives the European CE Mark Approval to Rule in or Rule Out Alzheimer’s-Related Amyloid Pathology

Shots: Roche has received CE Mark for Elecsys pTau217 to measure the phosphorylated Tau (pTau) 217 protein to help rule in or rule out Alzheimer’s-related amyloid pathology CE Mark was backed by retrospective real-world studies in early-stage Alzheimer’s pts, incl. Subjective Cognitive Decline, Mild Cognitive Impairment, & Mild Dementia, where individuals experience memory changes but…

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Labcorp Launches Elecsys pTau-181 Test to Help Rule Out Alzheimer’s Disease in the US

Shots: Labcorp has launched the Elecsys pTau-181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology in individuals (≥55yrs.) The test delivers a 97.9% negative predictive value to help rule out Alzheimer’s pathology in symptomatic pts & offers a less invasive, more accessible alternative to brain scans or lumbar punctures…

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Roche

Roche’s Elecsys pTau181 Test Receives the US FDA’s Clearance to Rule Out Alzheimer’s Disease

Shots: The US FDA has cleared the Elecsys pTau181 test to measure phosphorylated Tau 181 protein to help rule out Alzheimer’s-related amyloid pathology in individuals (≥55yrs.) Elecsys pTau181 was evaluated in a non-interventional study of 312 participants, showing 97.9% negative predictive value (NPV) in an early disease-stage, low-prevalence population Elecsys pTau217 is an in-vitro diagnostic…

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