
Pharmaceutical Product R&D and Manufacturer

In Vitro Diagnostic Instrument Manufacturer
Tokyo, July 201926th/PR Newswire/ -- Eisai Co., Ltd. (headquartered in Tokyo, Japan; current President: Haruo Naito; hereinafter referred to as “Eisai”) presented its latest research at the 2019 Alzheimer’s Association International Conference (AAIC), demonstrating high-precision measurement and evaluation of amyloid in plasma and cerebrospinal fluid (CSF) using a newly developed automated protein assay system. (Beta)(A(Betacorrelation). This system was jointly developed by Eisai and Sysmex Corporation (headquartered in Hyogo Prefecture, Japan; Chairman and CEO: Hisashi Ietsugu; hereinafter referred to as “Sysmex”), utilizing the fully automated immunoassay system HISCL™.*1Simplified Blood-Based Diagnosis for Alzheimer’s Disease (AD) Patients (Poster Presentation No.: P4-548). The Alzheimer’s Association International Conference (AAIC) was held in Los Angeles, California, USA, from July 14 to 18, 2019.
Aβ is a peptide composed of amino acid residues generated by the cleavage of amyloid precursor protein. Aβ consisting of 40 residues(Beta)1-40is a major substance that does not fluctuate significantly with the progression of AD. On the other hand, A composed of 42 residues(Beta)1-42A exhibits a high aggregation rate, detectable from the early stages of AD(Beta)1-42decrease. The absolute value of Aβ exhibits inter-individual differences and intra-individual variability; therefore, A in cerebrospinal fluid can be used(Beta)1-42/A(Beta)1-40the ratio to diagnose amyloid positivity or negativity.
This study established an automated protein detection system using the HISCL™ series of fully automated immunoassay systems to detect A in plasma.(Beta)1-42/A(Beta)1-40the ratio to A in cerebrospinal fluid(Beta)1-42/A(Beta)1-40The correlation between the ratios was studied to establish a simple blood-based diagnostic method for Alzheimer's disease (AD). This analytical system can process small-volume samples (e.g., 10–30μL) Perform automated immunoassay, and its A in plasma(Beta)The analysis may have sufficient sensitivity and high reliability. We used samples from elderly individuals with normal cognitive function, patients with mild cognitive impairment (MCI), and AD patients, conducting the study using the HISCL™ series. The results showed that plasma A(Beta)1- 42/A(Beta)1-4the ratio to A in cerebrospinal fluid(Beta)1-42/A(Beta)1-40correlation between the ratios (Spearman's rank correlation coefficient (rs)*2=0.502, p<0.001), therefore, by measuring A in plasma(Beta)1-42/A(Beta)1-40the ratio can provide insights into the progression of brain tissue pathology. To further evaluate clinical utility, Eisai plans to examine plasma A(Beta)1-42/A(Beta)1-40Correlation between the ratio and amyloid PET imaging.
Drawing on over 35 years of experience in drug development for Alzheimer’s disease/dementia, Eisai strives to prevent and treat dementia through comprehensive, multidimensional approaches, including the establishment of novel diagnostic methods, thereby meeting the diverse needs of patients and their families and enhancing their well-being.
*1 HISCL™ is a trademark of Sysmex Corporation.
*2 The correlation coefficient indicates the strength of the relationship between two variables derived from two quantitative data distributions. In this analysis, the Spearman rank correlation coefficient (rs), a correlation index derived from ranked data, was calculated.