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The number of patients with dementia in Japan is predicted to increase from approximately 4.6 million in 2012 (about 1/7 of elderly people aged 65 years or older) to 6.75–7.3 million in 2025 (about 1/5 of the same group),¹ thus becoming a major social issue with the advent of an aging society. 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.

 

Meanwhile, there has been an increase in the development of new therapeutic drugs worldwide that address the underlying pathology of Alzheimer’s disease in recent years. In the U.S., lecanemab² (generic name), jointly developed by Eisai Co., Ltd. and Biogen Inc., was granted accelerated approval as a treatment for Alzheimer’s disease by the Food and Drug Administration (FDA) in January 2023. In Japan, Eisai Co., Ltd. submitted an application for approval of the manufacturing and marketing of lecanemab on January 16, 2023, and in the same month, Lecanemab was designated for priority review by the Ministry of Health, Labour and Welfare (MHLW) in Japan.³ The appropriate use and dissemination of the drugs require technology to identify the accumulation of Aβ in the brain. However, conventional testing methods such as amyloid PET testing and cerebrospinal fluid testing have issues in terms of their invasiveness and cost. Therefore, there is an increasing need for less invasive and simpler testing methods for the clinical implementation of therapeutic drugs.

 

Sysmex has been developing a technology to more quickly and readily identify the accumulation of Aβ in the brain in order to solve issues in the diagnosis of Alzheimer's disease. In February 2016, Sysmex and Eisai Co., Ltd. entered into a comprehensive non-exclusive collaboration agreement for the creation of new diagnostic reagents in the field of dementia, and have been developing the Products by utilizing each company’s technologies and knowledge.

 

The Products assist in identifying the level of accumulation of Aβ in the brain by measuring the ratio of Aβ peptides (the 1-42 and 1-40 peptides) in the blood using Sysmex’s HISCL-Series, which employs chemiluminescence enzyme immunoassay (CLEIA) as its measurement principle. The Products are Japan’s first blood biomarkers approved as in vitro diagnostics in the field of dementia and enables minimally invasive, simple, and rapid testings. Therefore, testing using the Products reduces the physical, emotional, and financial burden on patients with suspected Aβ accumulation in the brain. Furthermore, the Products are expected to contribute to early diagnosis and early determination of optimal treatment plans for patients. In addition, automated assays using the HISCL-Series— which requires only 10 to 30 μL of blood (plasma) with a measurement time of just 17 minutes—will also help improve the efficiency and standardization of testing.

 

To expand the opportunities for patients to receive this testing, we plan to promote cooperation with related academies and key opinion leaders (KOLs) toward listing in diagnostic guidelines and its coverage by Japanese national health insurance.

 

Sysmex will continue to establish and promote the widespread use of its diagnostic technologies in Japan and overseas in order to improve people’s lifetime healthcare journey⁴, supporting the universal desire of people to live long and healthy lives.