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Peer-Reviewed Publication
Alzheimers Dement2025;21(9):e70707.September 1, 2025Journal Article

Combining Lumipulse p-tau217 and Aβ42/40 as confirmatory tests for Aβ positivity prior to disease-modifying therapy.

James D Doecke1,2, Ahmed Chenna3, Mintzu Lo3, Youssouf Badal3, Brandon Yee3, Robert Martone4, Christos Petropoulos3, Christopher J Fowler5, Simon Laws6, Stephanie R Rainey-Smith2,7,8,9, Ralph N Martins7,10, Christopher C Rowe5,11, Colin L Masters5, John Winslow3
1Australian E-Health Research Centre, CSIRO, Brisbane, Australia.
2School of Medical and Health Sciences, Edith Cowan University, Joondalup, Western Australia, Australia.
3Labcorp-Monogram Biosciences, South San Francisco, California, USA.
4Labcorp Drug Development, Indianapolis, Indiana, USA.
5The Florey Institute of Neuroscience and Mental Health, Parkville, Victoria, Australia.
6Centre for Precision Health, Edith Cowan University, Joondalup, Western Australia, Australia.
7Centre for Healthy Ageing, Health Futures Institute, Murdoch University, Murdoch, Western Australia, Australia.
8Alzheimer's Research Australia, Sarich Neuroscience Research Institute, Nedlands, Western Australia, Australia.
9School of Psychological Science, University of Western Australia, Crawley, Western Australia, Australia.
10Department of Biomedical Sciences, Macquarie University, Sydney, New South Wales, Australia.
11Department of Molecular Imaging & Therapy and Centre for PET, Austin Health, Heidelberg, Victoria, Australia.

Abstract

INTRODUCTION: For a blood-based biomarker to be considered a confirmatory test for the detection of abnormal amyloid beta (Aβ) levels, the sensitivity and specificity must be equivalent to that of current cerebrospinal fluid tests. METHODS: In the current study we assessed the ability of phosphorylated tau (p-tau)217 and Aβ42/40 from the Lumipulse G p-tau217 and β-amyloid ratio (1-42/1-40) tests,…

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