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Principal Investigator  
Principal Investigator's Name: James Koch
Institution: Fujirebio Diagnostics, Inc.
Department: Analytical Research & Development
Country:
Proposed Analysis: In 2017, Fujirebio was granted access to 422 blinded CSF samples from ADNI GO/2 for future testing on our Lumipulse platform. ¬¬Per the approval letter, it states that we will be provided with an unblinding code after sample testing so that we can acquire all of the sample’s data (e.g. clinical/biomarker). Given our FDA feedback, we need to perform adjudication on ADNI patient scans. This will be a lengthy process. As a result, Fujirebio would like to know if it would be possible to acquire the PET scans associated with these 422 blinded CSF samples (e.g. PET scan and blinded sample ID matching our CSF samples). Ideally, this would allow us to begin the adjudication process, while we complete our planned CSF testing by years end. To maintain blinding, all individuals involved with CSF testing will be blinded to the adjudication process/results.
Additional Investigators  
Investigator's Name: Rianne Esquivel
Proposed Analysis: The purpose of this study is to test CSF samples from the Alzheimer’s Disease Neuroimaging Initiative (ADNI) sample bank to obtain a minimum positive percent agreement of 86% and a corresponding minimum negative percent agreement of 90% when comparing the Lumipulse G β-Amyloid Ratio (1-42/1-40) result to the corresponding Positron Emission Tomography (PET) result.