Eisai: Sysmex Presents Academic Report with a View to Creating a Simple Method of Diagnosing Alzheimer’s Disease Using Blood

TOKYO, Nov 9, 2020 – (JCN Newswire) – Sysmex Corporation and Eisai Co., Ltd. announced that the most recent data from the project to develop a method of diagnosing Alzheimer’s disease (AD) using blood plasma was presented at the 13th Clinical Trials on Alzheimer’s Disease (CTAD) conference, held virtually from November 4 to 7, 2020. Sysmex demonstrated on behalf of the two companies the performance of the amyloid beta (Abeta) in plasma measured on Sysmex’s HISCLTM fully automated immunoassay analyzers in predicting amyloid pathology as defined by amyloid positron emission tomography (PET) imaging on the centiloid scale.(1)

The total number of those living with dementia across the world is projected to reach 82 million in 2030 and 152 million in 2050, with the total global societal cost of dementia stemming from direct medical and social care costs and lower productivity being estimated to reach 2 trillion USD in 2030.(6) In Japan, the number of those with dementia is thought to have reached approximately 4.62 million in 2012 and is projected to grow to 7.30 million in 20257, with the total societal cost of this disease is estimated to be equivalent to 4.1%8 of the gross domestic product (GDP) in 2025 (25.8 trillion yen9). Of these sufferers, those living with AD are thought to account for more than 60% of those living with dementia.(7)

It is conceivable that AD is a disease that results in synaptic dysfunction and neuronal cell death due to tau deposition in neurons triggered by Abeta aggregation on the outside of neurons. These brain changes cause cognitive impairment and psychological and behavioral symptoms, suggesting that the Abeta aggregation and accumulation inside the brain is caused by AD before the presence of cognitive impairment appears, thus, it is believed that early diagnosis and early intervention is more effective in therapies targeting Abeta. Currently, amyloid PET and Abeta ratio in cerebrospinal fluid (CSF) are used for detecting amyloid aggregates in the brain, but this puts a significant burden on patients in terms of access, costs, and their physical wellbeing.(10)

Sysmex and Eisai are working to create new diagnostic technologies for the prevention and treatment of dementia. Accordingly, the overarching aim is to contribute to the advancement of healthcare and improve the quality of life for those living with the disease and their families.

Terminology
(1) A standardization scale for integration analysis of PET SUVR values as measured by different amyloid PET imaging probes.
(2) Trained doctors qualitatively distinguish amyloid PET positive from amyloid negative subjects by visually reading images.
(3) Klunk WE et al, Alzheimer’s Dementia (2014)
(4) Assesses how correlated two sets of data are based on two quantitative data distributions.
For the purpose of this analysis, Spearman’s rank correlation coefficient (rs), which is a
correlation index as determined by the rankings of the two variables, was calculated.
(5) Schindler SE et al, Neurology (2019)
(6) World Alzheimer Report 2018
(7) Promotion of Comprehensive Measures against Dementia, Ministry of Health, Labour and
Welfare
(8) Study on Economic Impact of Dementia in Japan, 2014 Health Labour Sciences Research
Grant Annual Report
(9) Estimated by Sysmex based on Japan’s Medium-term Economic Outlook (February 2018),
Daiwa Institute of Research
(10) Abeta is a peptide made of amino-acid residues removed from amyloid precursor protein. Many of them are Abeta1-40, which is comprised of 40-residues, and the Abeta1-40 level does not fluctuate significantly as AD progresses. Comprised of 42-residues, Abeta1-42, on the other hand, is highly cohesive and decreases in cerebrospinal fluid (CSF) from the early stages of AD. It is believed that Abeta’s absolute values show individual and intrinsic variability but that the plasma Abeta1-42/Abeta1-40 ratio remains unchanged. It has also been reported that the plasma Abeta1-42/Abeta1-40 ratio in CSF shows a high correlation with amyloid PET.

About the collaboration between Sysmex and Eisai

In February 2016, Sysmex and Eisai signed a comprehensive non-exclusive agreement aimed at the development of new diagnostic tests in the field of dementia. By leveraging each other’s technologies and knowledge, the objective has been to discover next-generation diagnostic reagents that will enable early diagnosis of dementia, selection of the most appropriate treatment options, and regular monitoring of the effects of such treatments. At the 12th CTAD held in December 2019, the two companies reported on the performance of the plasma Abeta ratio measured on a fully automated immunoassay system HISCL in predicting the amyloid PET scan results (sensitivity: 73%, specificity: 71% [AUC = 0.74]), thus demonstrating the potential to predict amyloid pathology in the brain using the plasma Abeta ratio.* This finding was expected to lead to the development of a simple method of diagnosing Alzheimer’s disease using blood.

*https://www.sysmex.co.jp/en/news/2019/191209.html https://www.eisai.com/news/2019/news201990.html

About Eisai

Eisai Co., Ltd. is a leading global research and development-based pharmaceutical company headquartered in Japan. We define our corporate mission as “giving first thought to patients and their families and to increasing the benefits health care provides,” which we call our human health care (hhc) philosophy. With approximately 10,000 employees working across our global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to address unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology. As a global pharmaceutical company, our mission extends to patients around the world through our investment and participation in partnership-based initiatives to improve access to medicines in developing and emerging countries.

For more information about Eisai Co., Ltd., please visit https://www.eisai.com

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