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Nov. 04, 2025Press Release

Sysmex Launches Two Testing Parameters for Immunoassay Panel Related to Hypertension, Starting from Japan

- Contributing to Early Diagnosis and Prompt Treatment of Primary Aldosteronism -

Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) announces that it has launched the "HISCL^TM Aldosterone Assay Kit" and the "HISCL^TM Renin Assay Kit" ("the assay kits"), immunoassay panels that support early diagnosis of primary aldosteronism,¹ one of the causes of hypertension in Japan, on October 31, 2025. By expanding the testing parameters for the Automated Immunoassay System HISCL-5000/HISCL-800 ("HISCL-Series"),² we will be able to meet wider laboratory needs.

Under its Long-Term Corporate Strategy, Sysmex is promoting the expansion of its range of immunoassay testing parameters to strengthen global market penetration. In recent years, the company has been strengthening its testing lineup in the field of endocrine diseases, such as diabetes and gynecological hormone parameters, and the launch of the assay kits will further enhance the endocrine disease panel of the HISCL-Series.

The newly launched assay kits will enable rapid and highly sensitive measurement of aldosterone and renin when used with the HISCL-Series installed in hospitals. This will contribute to the early diagnosis of primary aldosteronism, the determination of treatment plans, and even a reduction in the length of hospital stays for patients.

At Sysmex, we will continue to accelerate business expansion globally by rapidly expanding immunoassay testing parameters, including through the effective use of alliances. Furthermore, through these efforts, we will provide high-value-added testing parameters that contribute to reducing the burden on patients and improving the quality of testing, thereby delivering anshin (peace of mind) to our customers.

Product Overview

Generic name (JMDN)	Aldosterone Kit for blood test	Active Renin Kit
Product name	HISCL™ Aldosterone Assay Kit	HISCL™ Renin Assay Kit
In vitro diagnostics notification/authorization number in Japan	Notification number: 13E1X80078003007	Authorization number: 307AAEZX00044000
Intended use	Measuring aldosterone in serum or plasma	Measuring active renin concentration in serum or plasma
Legal manufacturer	KAINOS Laboratories, Inc.	KAINOS Laboratories, Inc.
Seller	Sysmex Corporation	Sysmex Corporation
Target market	Japan (To be expanded gradually outside Japan)	Japan (To be expanded gradually outside Japan)
Launch	October 31, 2025	October 31, 2025

Terminology

	1	Primary aldosteronism:
		Primary aldosteronism is a disease in which blood pressure rises due to an excess of the hormone aldosterone secreted by the adrenal glands. It is estimated that approximately 5-10% of hypertensive patients in Japan are affected by this disease. Because there is a high risk of complications such as cardiovascular disease, stroke, or kidney disorder, diagnostic guidelines recommend early diagnosis and prompt decision-making on treatment plans. The guidelines state that it is effective to test for the two hormones, aldosterone and renin. However, testing is currently outsourced to external testing institutions, and the time it takes to reach a diagnosis is problematic. Therefore, there is a need to establish a rapid testing system by promoting in-hospital testing.

	2	HISCL-Series:

Product name	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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