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Proceedings of the National Academy of Sciences

Head-to-head comparison of brain-derived pTau217 and total pTau217 for brain amyloid and tau pathology classification

  • March 2, 2026
  • Nancy Y. Ip, et al., Hong Kong University of Science and Technology
Product:
NULISAqpcr BD-pTau217
Topic:
CNS
Disease Area:
Alzheimer's Disease
Sample Type:
Plasma
Back to Publications​
  • March 2, 2026
  • Nancy Ip, et al., Hong Kong University of Science and Technology
Topic/Product:
NULISAqpcr BD-pTau217
Disease Area:
Alzheimer's Disease
Sample Type:
Plasma

Abstract

Phosphorylated-tau 217 (pTau217) is currently the most promising blood-based biomarker for accurately detecting Alzheimer’s disease (AD) pathology. However, interference from peripheral tau species in the kidneys or peripheral nerves can hinder diagnostic precision. Recently developed brain-derived pTau217 (BD-pTau217) assays emerge as highly specific tools for detecting AD-related pathological changes in the brain. In this study, we conducted a head-to-head comparison of the NULISAqpcr BD-pTau217 assay and Simoa ALZpath total p-Tau217 assay in two independent, amyloid-PET–characterized Chinese cohorts. Our results demonstrate a strong correlation between BD-pTau217 and total pTau217 (ρ = 0.89 to 0.90), with BD-pTau217 showing significantly reduced interference from kidney dysfunction, as evidenced by weaker associations with blood levels of urea (ρBD-pTau217 = 0.02 to 0.06, ρTotal-pTau217 = 0.06 to 0.12) and creatinine (ρBD-pTau217 = 0.03 to 0.08, ρTotal-pTau217 = 0.16 to 0.18). Moreover, BD-pTau217 is more strongly associated with amyloid-PET Centiloid values (ρBD-pTau217 = 0.78 to 0.80, ρTotal-pTau217 = 0.74 to 0.77) and exhibits superior classification performance for amyloid-β (Aβ) pathology (area under the curve [AUC]BD-pTau217 = 0.96 to 0.98, AUCTotal-pTau217 = 0.94 to 0.97). Furthermore, BD-pTau217 outperforms total pTau217 for identifying tau-positive individuals within the Aβ-positive group (AUCBD-pTau217 = 0.89, AUCTotal-pTau217 = 0.78), facilitating more accurate disease staging. These findings underscore BD-pTau217 as a highly sensitive and specific blood-based biomarker for AD that has significant potential for early detection, precise classification, and staging of AD-related brain pathology in clinical practice.
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Authors & Affiliations

Yuanbing Jiangᵃᵇ, Wenyue Zhengᵃᵇ, Zengjie Xiaᵃ, Wan Wa Wongᵃ, Lily K. W. Chengᵃᵇ, Fanny C. Ipᵃᵇᶜ, Siu Man Choiᵈ, Andrew L. T. Chanᵈ, Ching Yu Lamᵉ, Ka Shing Hoᶠ, Chun Keung Shumᶠ, Jacqueline K. Y. Yuenᵍ, Yat Fung Sheaᵍ, Hok Man Waiʰ, Vincent C. T. Mokᶦʲ, Timothy C. Y. Kwokʲ, Kin Y. Mokᵃᵇᵏ, Hiu Yi Wongᵃᵇ, Henrik Zetterbergᵇᵏˡᵐⁿᵒᵖᵠ, Amy K. Y. Fuᵃᵇᶜʳ, and Nancy Y. Ipᵃᵇᶜʳ

ᵃ Division of Life Science, State Key Laboratory of Nervous System Disorders and Daniel and Mayce Yu Molecular Neuroscience Center, The Hong Kong University of Science and Technology, Hong Kong Special Administrative Region, China
ᵇ InnoHK Hong Kong Center for Neurodegenerative Diseases, Hong Kong Special Administrative Region, China
ᶜ Guangdong Provincial Key Laboratory of Brain Science, Disease and Drug Development, Hong Kong University of Science and Technology Shenzhen Research Institute, Shenzhen–Hong Kong Institute of Brain Science, Shenzhen, Guangdong 518057, China
ᵈ Department of Medicine, Queen Elizabeth Hospital, Hospital Authority, Hong Kong Special Administrative Region, China
ᵉ Department of Medicine and Geriatrics, Ruttonjee & Tang Shiu Kin Hospitals, Hong Kong Special Administrative Region, China
ᶠ Department of Medicine and Geriatrics, Tuen Mun Hospital, New Territories West Cluster, Hospital Authority, Tuen Mun, Hong Kong Special Administrative Region, China
ᵍ Division of Geriatrics, Department of Medicine, School of Clinical Medicine, The University of Hong Kong, Pokfulam, Hong Kong Special Administrative Region, China
ʰ Department of Medicine and Geriatrics, United Christian Hospital, Hospital Authority, Kwun Tong, Hong Kong Special Administrative Region, China
ᶦ Division of Neurology, Department of Medicine and Therapeutics, Lau Tat-chuen Research Centre of Brain Degenerative Diseases in Chinese, Gerald Choa Neuroscience Institute, Lui Che Woo Institute of Innovative Medicine, Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region, China
ʲ Division of Geriatrics, Department of Medicine and Therapeutics, Therese Pei Fong Chow Research Centre for Prevention of Dementia, The Chinese University of Hong Kong, Shatin, Hong Kong Special Administrative Region, China
ᵏ Department of Neurodegenerative Disease, Queen Square Institute of Neurology, University College London, London WC1N 3BG, United Kingdom
ˡ United Kingdom Dementia Research Institute, University College London, London NW1 3BT, United Kingdom
ᵐ Department of Psychiatry and Neurochemistry, Institute of Neuroscience and Physiology, Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden
ⁿ Clinical Neurochemistry Laboratory, Sahlgrenska University Hospital, Mölndal SE-43180, Sweden
ᵒ Wisconsin Alzheimer’s Disease Research Center, University of Wisconsin School of Medicine and Public Health, University of Wisconsin–Madison, Madison, WI 53792-2420, USA
ᵖ Department of Pathology and Laboratory Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI 53705, USA
ᵠ Centre for Brain Research, Indian Institute of Science, Bangalore 560012, India
ʳ Shenzhen Institutes of Advanced Technology–Hong Kong University of Science and Technology Joint Laboratory for Brain Science, Shenzhen, Guangdong 518055, China

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Steve Williams, MD, PhD

CSO

Dr. Willams serves as the company’s Chief Scientific Officer. He was previously Chief Medical Officer at Standard Biotools and at SomaLogic where he pioneered the discipline for discovery and validation of predictive, diagnostic and prognostic models using machine-learning applied to large-plex proteomics. 20 such tests were used for drug characterization, safety and efficacy when incorporated in clinical drug trials at Pharma/Biotech and 17 different multivariate tests were validated and translated into regulated healthcare uses. Prior to SomaLogic, Dr. Williams was at Pfizer in the UK and the USA as a clinical triallist in Translational Medicine, and subsequently as VP, Global Clinical Technology. He sat on the National Advisory Council for the National Institute of Biomedical Imaging and Bioengineering, the Executive Committee for the FNIH Biomarkers Consortium, and worked with FDA and PhRMA on developing evidentiary standards for biomarker qualification. Dr. William’s medical training was in London, at Charing Cross and Westminster Medical School, followed by a PhD in medicine/physiology at the same institution and training in Radiology at the University of Newcastle Upon Tyne. Steve is co-inventor on 26 proteomics patents and author/coauthor on multiple foundational proteomics manuscripts.

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Justin McAnear

CFO

Mr. McAnear serves as the company’s Chief Financial Officer. He brings over 25 years of operational and financial leadership experience across various sectors and was instrumental in taking 10x Genomics public in 2019, serving as its CFO for over five years. Mr. McAnear served for over 3 years as Tesla’s VP of Worldwide Finance and Operations, supporting landmark initiatives such as the Model X and Model 3 launches and Solar City acquisition.  He also held various roles at Apple and J&J earlier in his career and served as a naval officer and aviator for over 9 years.