Eisai, Sysmex present data on blood plasma-based diagnostic test for Alzheimer’s

Currently, amyloid PET and Abeta ratio in cerebrospinal fluid are used for detecting amyloid aggregates in the brain but a blood-based diagnostic test could mean earlier and more regular monitoring of treatment for Alzheimer’s Disease

Sysmex Corporation and Eisai presented recent data from their project to develop a method of diagnosing Alzheimer’s disease (AD) using blood plasma at the 13th Clinical Trials on Alzheimer’s Disease (CTAD) conference, held virtually from November 4-7, 2020.

Sysmex demonstrated the performance of the amyloid beta (Abeta) in plasma measured on it’s HISCLTM fully automated immunoassay analysers in predicting amyloid pathology as defined by amyloid positron emission tomography (PET) imaging on the centiloid scale, a standardisation scale for integration analysis of PET SUVR values as measured by different amyloid PET imaging probes.

The researchers will be evaluating additional sample sets to further assess the clinical utility of their assay system.

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 in 2030, as per the World Alzheimer Report 2018.

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. Thus a blood-based diagnostic test could mean earlier and more regular monitoring of treatment for AD.

Sysmex and Eisai’s non-exclusive agreement signed in February 2016 is aimed at the development of new diagnostic tests in the field of dementia, by discovering 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 per cent, specificity: 71 per cent [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.