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Apr. 13, 2026Press Release

Sysmex Launches an Assay Kit for Identifying p-Tau217 in the Blood, a Biomarker Related to Alzheimer's Disease

Sysmex Corporation (HQ: Kobe, Japan; President: Iwane Matsui) announced that it has launched “HISCL™ p-Tau217 Assay Kit for Research Use” (“the Product”), a reagent for research purposes to identify a biomarker¹ related to Alzheimer's disease, namely blood p-Tau217² levels, in Europe in April 2026. Following the launch in Europe, the Product will be rolled out sequentially in Japan, the United States, South Korea, and Taiwan, contributing to accelerated global data acquisition for Alzheimer’s disease research.

Going forward, Sysmex will support the creation of new knowledge through collaborative research, both domestically and internationally, and promote initiatives aimed at applying for and obtaining regulatory approval as an in vitro diagnostic product. This will lead Sysmex to establish less burdensome testing and diagnostic techniques for patients and to promote their early dissemination both domestically and internationally.

In research on Alzheimer's disease and the development of new treatments, there is a need to establish biomarkers that can accurately assess pathological changes in the brain. However, conventional brain imaging and cerebrospinal fluid (CSF) tests are not only limited to facilities where they can be performed, but are also invasive and costly, placing a significant burden on patients. This has posed challenges in scaling up research and accumulating data. Against this backdrop, minimally invasive and simple evaluation methods using blood biomarkers are attracting attention as methods that are easier to implement, and these are expected to improve the efficiency of research and development.

Under the Long-Term Corporate Strategy, Sysmex is focused on creating high-value testing and diagnostic technologies that contribute to solving social issues. In the field of dementia, Sysmex is working to establish and commercialize blood biomarker measurement technologies. To date, Sysmex has launched reagents for blood-based amyloid β testing³using the HISCL™-Series in Japan and Europe, and has supplied the kit in the United States for LDT.⁴

The Product is an assay kit for research use that enables fully automated measurement of p-Tau217, a blood biomarker that has attracted attention in research for its association with pathological changes in Alzheimer’s disease, using the HISCL™-5000/HISCL™-800, Automated Immunoassay System (“HISCL-Series”).⁵ The automated measurement capabilities of the HISCL-Series will enable research institutions and pharmaceutical companies to conduct evaluations using collected blood samples more quickly and at larger scale, supporting data acquisition in biomarker research and drug discovery research.

Through the Product, Sysmex will support the verification of measurement performance and association with pathological changes in research settings, as well as the accumulation of knowledge, and will pursue product development with a view to future use in clinical practice.

Product Overview *The Product is an assay kit for research. The Product is not intended for use in diagnosis.

Name of parameter	p-Tau217 kit
Product name	HISCL™ p-Tau217 Assay Kit for Research Use
Intended use	Quantitative measurement of p-Tau217 in plasma
Manufacturer and seller	Sysmex Corporation
Target market	Europe *To be released sequentially in Japan, the United States, South Korea, and Taiwan.
Launch	April 2026

Product Images

References

		June 22, 2023 news release: “Sysmex Launches an Assay Kit to Identify Amyloid Beta (Aβ) Accumulation in the Brain, a Cause of Alzheimer’s Disease, Using a Small Amount of Blood” https://www.sysmex.co.jp/en/news/2023/230622.html

		August 29, 2023 news release: “Sysmex Begins Supplying Reagents for U.S. Based Laboratory Developed Test (LDT) Measuring Amyloid Beta (Aβ) in Blood” https://www.sysmex.co.jp/en/news/2023/230829.html

		December 25, 2023 news release: “Sysmex Expands Sales of Its Reagents for Blood-based Amyloid β Testing to Europe” https://www.sysmex.co.jp/en/news/2023/231225.html

Terminology

Biomarkers:
Internal indicators that provide clues about the state and changes in a disease, such as proteins found in the blood.

p-Tau217:
Abbreviation for phosphorylated tau-217. p-Tau217 refers to a molecular species in which the 217th site of the tau protein is phosphorylated, and which is being studied as an indicator related to the pathogenesis of Alzheimer's disease.

Reagents for blood-based amyloid β testing：

Product names	Registration number in Japan
HISCL™ β-Amyloid 1-42 Assay Kit	30400EZX00104000
HISCL™ β-Amyloid 1-40 Assay Kit	30400EZX00105000

LDT:
A laboratory developed test (LDT) is a type of in vitro diagnostic test that is designed, manufactured, and used within a single laboratory.

HISCL™-Series:

Product names	Medical Device Marketing Authorization Number in Japan
Automated Immunoassay System HISCL™-5000	28B1X10014000011
Automated Immunoassay System HISCL™-800	28B1X10014000012

About Sysmex Corporation

Sysmex Corporation, headquartered in Kobe, Japan, is a global leader in in vitro diagnostics. Since its foundation in 1968, Sysmex has focused on diagnostics as the core of its business, and today, it supports the health of people in over 190 countries and regions worldwide. Sysmex continues to innovate in diagnostics, and to collaboratively create unique values in the areas of personalized medicine and novel treatments, under its long-term vision of "Together for a better healthcare journey." Through its unique technology, solutions, and co-creation with various partners, Sysmex delivers new value and addresses the universal desire of people to live longer and healthier lives. For more information about Sysmex, please visit www.sysmex.co.jp/en/.
* "Healthcare journey" is a trademark of Sysmex Corporation, registered in Japan.

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The purpose of this news release is to communicate our business activities to our stakeholders. It may or may not include information about Sysmex's products or their research and development, but this is not intended for promotion, advertising or medical advice. The information contained in this news release is current as of the date of the announcement but may be subject to change without prior notice.

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