Performance of upper-arm capillary blood collection for Alzheimer’s disease and central nervous system biomarkers: comparison of Tasso+ and venous plasma

Product:

CNS Disease Panel 120

Topic:

Neurology

Disease Area:

Alzheimer's Disease

Sample Type:

Venous and Tasso+ plasma

Abstract

INTRODUCTION Novel capillary-blood collection methods have not yet been evaluated for a wide range of central nervous system (CNS) and neurodegenerative disease-related proteins. Biomarkers of Alzheimer’s disease (AD) and related disorders (ADRD) collected from devices like the Tasso+, a minimally invasive upper-arm capillary blood collection device, must be compared to traditional venipuncture to assess for validity.

METHODS Participants underwent blood collection via traditional venipuncture and Tasso+ in a clinical research setting. The Nucleic Acid Linked Immuno-Sandwich Assay (NULISA) CNS panel was used for biomarker quantification in venous and Tasso-derived plasma.

RESULTS Eighty-three participants (age mean±SD 76.8±8.2 years, 79.5% cognitively unimpaired) completed blood collection. Little to no correlation was found between venous and Tasso+ plasma for p-tau217, but the correlation was improved by using a brain-derived (BD)-p-tau217/BD-p-tau181 ratio. Extremely strong correlations were found for neurofilament light (NfL) and glial fibrillary acidic protein (GFAP). Among the 131 biomarkers measured, 51 (38.9%) had a Pearson R ≥ 0.90; 27 (20.6%) had values between 0.70-0.90; 26 (19.9%) had values between 0.30-0.70; and 27 (20.6%) had values ≤0.30.

DISCUSSION The Tasso+ accurately measures NfL and GFAP, but caution is warranted when measuring other AD/ADRD biomarkers, as agreement with venous plasma appears to be protein or ratio dependent. These results highlight that important biomarker-specific differences must be considered when translating capillary blood collection approaches. They also further support foundations for development of these methods, highlighting both the opportunities and remaining challenges for translating the promise of blood-based biomarkers beyond AD/ADRD specialty clinics and research settings.

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Authors and Affiliations

Taraneh E. Atriᵃ, Marisa N. Denkingerᵃ, James Liuᵃ, Alpana Singhᵃ, Michelle Surdynᵃ, Victoria A. Brownᵃ, Guadalupe Martinezᵃ, Marlene Teranᵃ, Vanessa Sozaᵃ, Angela Kuramotoᵃ, Tainá M. Marquesᵃ, Jessica B. Langbaumᵇ, Alireza Atriᵃ˒ᵇ˒ᶜ, and Nicholas J. Ashtonᵃ˒ᵇ˒ᵈ*

ᵃ Banner Sun Health Research Institute, Banner Health, Sun City, Arizona, USA
ᵇ Banner Alzheimer’s Institute, Banner Health, Phoenix, Arizona, USA
ᶜ Mass General Brigham and Harvard Medical School, Boston, USA
ᵈ Department of Psychiatry and Neurochemistry Institute of Neuroscience and Physiology, The Sahlgrenska Academy at the University of Gothenburg, Mölndal, Sweden

* Corresponding author: Nicholas J. Ashton

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.

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.