The Quest for a More Accessible Dementia Diagnosis

- How Testing Can Support a Better Healthcare Journey for Patients -

Sysmex has a history of over 50 years in the field of in vitro diagnostics, which examines blood and other samples and now boasts a value chain that extends from R&D of testing analyzers and reagents to procurement and production, sales, and support services. The company aims to provide new value to all individuals at every stage of their lifelong healthcare journey through early detection of disease, disease prevention, and selection of optimal treatment. In an interview, our Chief Technology Officer, Tomokazu Yoshida, talks about his determination and his struggle to establish a new testing method in the field of dementia.

Establishment of a Minimally Invasive, Simple Testing and Diagnostic Technology Supporting a Paradigm Shift in Alzheimer’s Disease Treatment

The therapeutic drug lecanemab (generic name),1 a novel treatment aimed at slowing the progression of Alzheimer's disease by removing amyloid β (Aβ) plaques in the brain, was launched in Japan in December 2023. For many years, only symptomatic treatments were available for Alzheimer’s disease, but the emergence of this new drug, which is designed to target a substance that contributes to the onset of the disease, marks a turning point in treatment. Early detection of the disease through testing is key to the effectiveness of this new drug. In June 2023, Sysmex launched testing reagents that assist in identifying the status of Aβ accumulation in the brain from just a tiny amount of blood in Japan. This technology, which we have developed, will lead to testing that has less physical and mental burden on patients than existing methods, and can be incorporated into local medical institutions that patients are comfortable with. If the number of people undergoing tests can be increased by lessening the burden of testing and improving access, this will result in early detection of the disease in a greater number of patients. The testing reagent is the fruit of efforts over 10 years by CTO Tomokazu Yoshida, a Member of the Managing Board and Senior Executive Officer, who clung to his firmly held desire to contribute to medicine through the development of this test.

A Decade Spent Working with a Desire to Contribute to the Evolution of Healthcare by Expanding the Value of Testing

“To date, Sysmex has taken the lead with various different innovations in the field of in vitro diagnostics,” says Yoshida. “At the same time, I very much wanted to help bring about a completely new type of medical care by using my experience from my previous position in a pharmaceutical company to combine Sysmex’s testing and diagnostics technology with the knowledge assets of the pharmaceutical industry.” Conventional testing has always been about detecting abnormalities, but Yoshida was searching for a way to broaden this so that it linked with improving treatment opportunities.
Beginning in 2013, Yoshida’s approach was to visit numerous pharmaceutical companies to share ideas about how the various different types of information obtained from blood could be used in medical care. It was a slow process, and Yoshida worked steadily for a couple of years, even developing prototypes to let other companies appreciate what Sysmex could offer as a maker of testing analyzers and reagents. As a result of his efforts, in February 2016 Sysmex entered into collaboration with Eisai Co., Ltd., a company with extensive experience and expertise in the field of dementia which is focusing its efforts on new drug development. The collaboration between the two companies is aimed at the development of next-generation diagnostics that will allow early diagnosis, selection of treatment options, and monitoring of the effects of treatment for dementia. “We were absolutely determined to find a way to help in this area, where for many years only symptomatic treatment had been available,” says Yoshida, looking back on how he felt at the start.
Subsequently, in 2018 another company published a report that the accumulation of Aβ in the brain, which is believed to be one of the causes of Alzheimer’s disease, could be measured through biomarkers in the blood. This greatly sped up research and development of blood-based diagnostic technology. Finally, almost a decade since Yoshida embarked on his journey, in December 2022 the technology for a blood test to identify Aβ accumulation in the brain was established and approved in Japan as an in vitro diagnostic product. This was the moment that both Yoshida’s aspirations and the future that Sysmex was aiming for took shape. “I got the feeling that the importance of detecting Alzheimer’s disease in patients at an early stage through a test in order to offer opportunities for treatment—in other words, the value of testing—was slowly spreading, not just among pharmaceutical companies but also among society as a whole,” he says. 

Testing and Diagnostics Pave the Way to a Better Healthcare Journey for Everyone

“It is a huge step for Sysmex’s product to be approved first in Japan as a diagnostic that can measure Aβ accumulation in the brain by using blood,” says Yoshida, looking back on the road to regulatory approval in Japan. “This really embodies how testing leads to appropriate treatment and increases the value of the treatment.” 
The availability of this test reagent for measurement of Aβ in the blood has now spread from Japan to the U.S. and Europe. Sysmex is working on the social implementation of blood testing relating to dementia and is carrying out R&D aimed at expanding the range of blood-based biomarkers.
Yoshida is looking firmly to the future. “I am hoping that the blood Aβ test reagent will be a model case for future collaborations with a range of partners to generate new patterns of healthcare from the standpoint of testing,” he says. “To ensure a better healthcare journey for medical professionals, patients, and their families, we need to look at how to maintain health, how to detect signs of disease earlier, and how to link these to better healthcare. There is still so much that we can do.” As Yoshida speaks, his eyes light up with the possibilities that lie beyond today’s healthcare. 
Sysmex will continue to support each individual on his or her lifelong healthcare journey by contributing to the advancement of healthcare through collaboration with a range of stakeholders, untrammeled by the existing frameworks of testing and diagnostics.
1. Lecanemab (generic name):
A drug for the treatment of Alzheimer’s disease, jointly developed by Eisai Co., Ltd. and Biogen Inc. This is the world’s first drug shown to slow the progress of Alzheimer’s disease and was approved in the U.S. in July 2023, in Japan in September 2023, and in China in January 2024. An application for marketing approval in Europe was accepted in January 2023.

Related Information

▶ Sysmex’s Approach to Dementia

▶ Short Movie: Discover in 2 Minutes "Alzheimer’s Disease" - Why Timely Diagnosis Matters -


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