News

Mar. 28, 2024Press Release

Sysmex Begins Sales of Six Testing Parameters for the Immunoassay Panel Related to Gynecological and Gonadal Hormones in Japan

- Contributing to the Diagnosis and Treatment of Gynecological Disorders and Infertility Treatment -

Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) announces the launch of six testing parameters ("HISCL LH Assay Kit," "HISCL FSH Assay Kit," "HISCL Prolactin Assay Kit," "HISCL Estradiol Assay Kit," "HISCL Progesterone Assay Kit," and "HISCL Testosterone Assay Kit"; here after referred to as "the assay kits") for gynecological and gonadal hormone immunoassay panels in Japan, starting from March 28, 2024. The expansion of testing parameters for Automated Immunoassay System HISCL-5000/HISCL-800 ("HISCL-Series") will enable a wide range of laboratory needs to be addressed.

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.

The assay kits we are launching enable, with the use of the HISCL-Series, simple and rapid measurement of blood hormone levels, which will be useful for the diagnosis and treatment of gynecological disorders and infertility treatment. The addition of gynecology-related parameters to our reagent portfolio will help us meet diversified laboratory needs and improve testing efficiency.

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, including the effective use of alliances. 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

Name of parameter	LH	FSH	Prolactin
Generic name (JMDN)	Luteinizing hormone kit for blood test	Follicle stimulating hormone kit for blood test	Prolactin kit for blood test
Product name	HISCL™ LH Assay Kit	HISCL™ FSH Assay Kit	HISCL™ Prolactin Assay Kit
Notification number of marketing in Japan	13E1X80078003003	13E1X80078003002	13E1X80078003001
Intended use	Measuring the amount of luteinizing hormone (LH) in serum or plasma	Measuring the amount of follicle-stimulating hormone (FSH) in serum or plasm	Measuring the amount of prolactin in serum or plasm

Name of parameter	Estradiol	Progesterone	Testosterone
Generic name (JMDN)	Estradiol Kit	Progesterone kit	Testosterone kit for blood test
Product name	HISCL™ Estradiol Assay Kit	HISCL™ Progesterone Assay Kit	HISCL™ Testosterone Assay Kit
Notification number of marketing in Japan	13E1X80078003005	13E1X80078003006	13E1X80078003004
Intended use	Measuring the amount of estradiol in serum or plasma	Measuring the amount of progesterone in serum or plasm	Measuring the amount of testosterone in serum or plasm

	Manufacturer and seller:	KAINOS Laboratories, Inc.
	Seller:	Sysmex Corporation
	Target market:	Japan
	Launch:	March 28, 2024

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.
* "Healthcare journey" is a trademark of Sysmex Corporation, registered in Japan.

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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