March 22, 2022
Sysmex Corporation

Sysmex Presents Academic Report in Effort to Create a Simple Blood
Test to Diagnose Alzheimer’s Disease
The Content Presented at the International Conference on Alzheimer's & Parkinson's Diseases:(AD/PDTM 2022)

Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu; hereafter, “Sysmex”)
and ADx Neurosciences (HQ: Ghent, Belgium; CEO: Koen Dewaele) are conducting joint researchon the construction of a blood biomarker measurement system for dementia.
Sysmex Corporation announced today that an oral presentation on the basic evaluation of novelassay reagents for measurement of plasma Aβ1-40, Aβ1-42, p-Tau 181, t-Tau (total Tau) and NfL using
an HISCL™ fully automated immunoassay system had been delivered at the International
Conference on Alzheimer’s & Parkinson’s Diseases (AD/PDTM 2022) held from March 15 to 20, 2022
in Barcelona, Spain.
Presentation Plasma Biomarkers for Classification of AD Pathology by a Fully AutomatedtitleAuthors

Immunoassay System (HISCLTM series)

Kengo Ishiki1, Shunsuke Watanabe1, Kazuto Yamashita1, Teresa Lukaszewska2,Masahiro Miura1, Yasuhiro Irino1, Shigeki Iwanaga1, Toshiyuki Sato1, Eugeen
Vanmechelen3, Tomokazu Yoshida1
1Central Research Laboratories, Sysmex Corporation, Kobe, Japan; 2Sysmex R&D

Center Americas Inc., Mundelein, Illinois, USA; 3ADx Neurosciences, Ghent, Belgium
Type ofVirtual, On-Demand Oralpresentation
Overview of The ATN (A: Amyloid pathology, T: Tau pathology, N: neurodegeneration/neurologicalpresentation injury) classification is widely used in research as a means of classifying Alzheimer’sdisease (AD) based on pathology. At present, cerebrospinal fluid (CSF) test andneuroimaging test are necessary, but it is thought to be desirable to establish a simple
ATN classification system such as blood test in order to accelerate clinical application.
Our group has previously reported the development of novel assays for themeasurement of plasma Aβ1-40, Aβ1-42, plasma p-Tau 181*1 and plasma t-Tau using anHISCL fully automated immunoassay system (Sysmex) and the fact that significant
differences were observed between AD patients and a normal cognitive function(CN)subjects.

In the present study, we developed a measuring reagent for neurofilament light chain
protein (NfL) as a new candidate for the “N” category, with use of an HISCL
immunoassay system. We also verified clinical performance for Aβ1-40, Aβ1-42, p-Tau
181, Tau and NfL reagent using commercially available plasma and cerebrospinal
fluid (CSF) samples from mild cognitive impairment (MCI) and Alzheimer’s disease(AD) patients, and CN subjects.
(Results)
・

Analytical performance (repeatability, dilution linearity, spike and recovery)
achieved for p-Tau 181, Tau and NfL using plasma samples showed enoughanalytical performance to measure plasma biomarkers.

・The results for correlations (Spearman’s rank correlation coefficients*2)
between plasma and CSF were rs=0.49 for p-Tau 181 (p< 0.001), rs=0.40 forTau (p<0.005) and rs=0.37 for NfL (p<0.001) suggesting that plasma
biomarkers levels reflect the situation in the brain.

The above results suggested that plasma p-Tau 181 is a suitable candidate for the“T” category and that both plasma Tau and NfL may reflect neurodegeneration(category “N”)
[Notes]*1
It stands for phosphorylated tau protein. 181 indicates that the phosphorylation site of threonine
181, the 181st amino acid of the tau protein, is phosphorylated.
*2 Shows the extent of correlation between data from 2 quantitative data distributions. In thepresent analysis, we calculated Spearman’s rank correlation coefficients, which indicate
correlations between rank data.