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FDA Oks Marketing Of First In Vitro Diagnostic Test To Detect Alzheimer s Disease

WASHINGTON (dpa-AFX) - The U.S. Food and Drug Administration or FDA granted marketing authorization for the first in vitro diagnostic test for early detection of amyloid plaques associated with

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FDA approves marketing for new Alzheimer s early detection test

The Lumipulse G β-Amyloid Ratio (1-42/1-40) test is available at clinical laboratories nationwide for adult patients aged 55 years and older who are presenting with cognitive impairment and being evaluated for Alzheimer’s disease and other causes of cognitive decline.

United statesJeff shurenJason katzRadiological healthAlzheimer disease neuroimaging initiativeAlzheimer associationDrug administrationFujirebio diagnostics incSenior portfolio manager jason katzAmyloid ratioDisease neuroimaging initiative

Fujirebio Diagnostics Lumipulse® G β-Amyloid Ratio (1-42/1-40) In Vitro Diagnostic Test Receives Marketing Authorization for the Assessment of Alzheimer s Disease

Fujirebio Diagnostics Lumipulse® G β-Amyloid Ratio (1-42/1-40) In Vitro Diagnostic Test Receives Marketing Authorization for the Assessment of Alzheimer s Disease
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FDA Clears Diagnostic Test for Early Alzheimer s

The US Food and Drug Administration has cleared the first in vitro diagnostic test for early detection of Alzheimer s disease.

Jeff shurenRadiological healthAlzheimer disease neuroimaging initiativeDrug administrationFujirebio diagnostics incAmyloid ratioFujirebio diagnosticsDisease neuroimaging initiativeBreakthrough deviceMild cognitive impairmentPrimary progressive dementiaSenile dementiaCognitive deficitAmyloid plaquePositron emission tomography petPositron emission tomography

FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer s Disease

/PRNewswire/ The U.S. Food and Drug Administration today permitted marketing for the first in vitro diagnostic test for early detection of amyloid plaques.

United statesJim mckinneyJeff shurenRadiological healthAlzheimer disease neuroimaging initiativeNational institutes of healthDrug administrationFujirebio diagnostics incAmyloid ratioDisease neuroimaging initiativeFujirebio diagnosticsUs food and drug administration