News

Mar. 13, 2025Press Release

Sysmex Begins Sales of Diabetes Testing Panel Including HISCL™ C-Peptide Assay Kit in Japan

Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) will begin sales of the “HISCL C-Peptide Assay Kit” a C-peptide immunoassay parameter for diabetes, in Japan on March 13, 2025. By expanding the diabetes testing panel for the Automated Immunoassay System HISCL-5000/HISCL-800 (“HISCL-Series”),¹ in addition to the HISCL Insulin Assay Kit² currently on sale, we will be able to meet wider laboratory needs.

As part of long-term corporate strategies, Sysmex seeks to expand its business domain by strengthening existing businesses and creating new ones. In the existing immunochemistry field, Sysmex focuses on the expansion of testing parameters to accelerate global market penetration.

Determining insulin secretion levels is important in diagnosing and treating diabetes. However, while an individual is using insulin preparations, insulin testing alone cannot accurately determine how much insulin is being produced in the body. Therefore, it is essential to simultaneously perform a C-peptide test, which reflects the levels of insulin secreted in the body.

The newly launched “HISCL C-Peptide Assay Kit” is for the HISCL-Series, which simply and quickly measures serum C-peptide levels, allowing accurate determination of insulin secretion in the body. When combined with the HISCL Insulin Assay Kit,² it dramatically improves the accuracy of diabetes diagnosis and contributes to improved treatment outcomes.

At Sysmex, we will continue to accelerate business expansion globally in the field of immunochemistry by reinforcing our strengths in unique parameters such as dementia and hepatic fibrosis markers, while expanding our testing parameters as soon as possible. We remain committed to delivering anshin (peace of mind) to its customers through the continued expansion of high-value testing parameters that contribute to reducing patient burden and improve the quality of testing, as well as proactive global expansion.

Product Overview

Generic name (JMDN)	C-peptide kit for blood testing
Product name	HISCL™ C-Peptide Assay Kit
In vitro diagnostics notification number in Japan	28E1X80030000074
Intended use	Measuring for quantitative determination of C-peptide in human serum
Manufacturer and seller	Sysmex Corporation
Target market	Japan
Launch	March 13, 2025

Terminology

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

Product name	In vitro diagnostics notification number in Japan
HISCL™ Insulin Assay Kit	28A2X00030000050

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/.

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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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