Japan approves Sysmex's assay kit for detection of Alzheimer's

23 December 2022 | News

Manufacturing and marketing approval for an assay kit to identify Amyloid Beta (Aβ) accumulation in the brain

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Sysmex Corporation has received manufacturing and marketing approval in Japan for the HISCL β-Amyloid 1-42 Assay Kit and the HISCL β-Amyloid 1-40 Assay Kit as in vitro diagnostics to measure amyloid beta (Aβ) in the blood.

The product assists in identifying Aβ accumulation in the brain, which is a characteristic of Alzheimer's disease, by measuring Aβ levels in the blood using the company's automated immunoassay system HISCL-5000/HISCL-800.

The company is preparing for market introduction in Japan to give patients access to this minimally invasive and simple test as soon as possible.

Currently, more than 55 million people worldwide suffer from dementia, and with increasing life expectancy, this number is expected to rise to 130 million by 2050. Alzheimer's disease, which is the most common form of dementia and accounts for approximately 60%-70% of all cases, is caused by Aβ peptides accumulating in the brain, resulting in damage to nerve cells. Once damaged, it is difficult for nerve cells to regenerate, so early diagnosis and treatment are essential.

The diagnosis of Alzheimer's disease requires technology to identify the accumulation of Aβ in the brain. However, conventional testing methods have issues in terms of their invasiveness and cost, so there is a demand for less invasive and simpler testing and diagnostic techniques.