News

Sep. 30, 2024Press Release

Sysmex Launches “HISCL™ HIT IgG Assay Kit” Contributing to the Detection of Adverse Reactions to Heparin Therapy

Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) announced that it has launched the HISCL™ HIT IgG Assay Kit ("the assay kit") for measuring IgG antibodies against the complexes of platelet factor 4 and heparin in the Japanese market on September 27, 2024.

The assay kit is for our Automated Blood Coagulation Analyzers CN-6500/CN-3500 ("CN-6500/CN-3500”)¹ that incorporate the technology of the HISCL™-Series.² It achieves the high sensitivity and high specificity required in serological testing for heparin-induced thrombocytopenia ("HIT").³ By achieving high specificity, the assay kit reduces false positives, which are an issue in determining adverse reactions to heparin therapy. This, in turn, speeds up the diagnosis of HIT and enhances testing efficiency.

Heparin is administered to patients undergoing anticoagulant therapy for thrombosis and to patients undergoing hemodialysis to prevent blood clotting. However, heparin administered for therapeutic purposes may cause adverse reactions. To diagnose HIT, serological tests are performed to measure HIT antibodies. However, due to the lack of serological testing methods to obtain quick results with high specificity, only a limited number of medical institutions can perform these tests. As a result, even if HIT is suspected, test results may not be available immediately, which may delay treatment for the patient. Furthermore, even at medical institutions that perform the serological tests, the high rate of false positives may lead to issues including unnecessary changes to anticoagulants, which in turn increases treatment costs, resulting in inefficient medical care.

Our CN-6500/CN-3500 can simultaneously measure blood coagulation and serological testing parameters, allowing for rapid APTT testing, which is used to monitor alternative therapeutic drugs in the event of HIT development. This is expected to improve testing workflow and streamline procedures to meet the needs of clinical settings. This will not only enhance patients' quality of life but also drastically improve the operational efficiency of medical institutions.

Sysmex has strived to make testing more efficient, faster, and more accurate for diseases such as thrombocytopenia and platelet dysfunction, which have previously been difficult to diagnose early due to complex detection processes and for which sufficient testing has not been carried out. With the assay kit, Sysmex will further contribute to the management of thrombocytopenia and will continue to expand its range of testing parameters with high clinical value for platelet-related diseases. This will improve disease management while promoting business expansion and global operations.

Product Overview

Generic name (JMDN)	Platelet factor 4-heparin complex antibody kit
Product name	HISCL™ HIT IgG Assay Kit
in vitro diagnostics approval number in Japan	30500EZX00054000
Intended use	Measuring the amount of IgG antibodies against platelet factor 4 (PF4)-heparin complexes (HIT IgG antibodies) in plasma
Manufacturer and seller	Sysmex Corporation
Target market	Japan (To be expanded gradually outside Japan)
Launch	September 27, 2024

Terminology

1	Automated Blood Coagulation Analyzer CN-6500/ CN-3500:

Name	Medical Device Marketing Authorization Number in Japan
Automated Blood Coagulation Analyzer CN-6500	28B1X10014000057
Automated Blood Coagulation Analyzer CN-3500	28B1X10014000058

2	HISCL™-Series: A generic term for the Automated Immunoassay Systems HISCL™-5000/HISCL™-800

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

Heparin-induced thrombocytopenia (HIT):

A disease in which the use of heparin causes thrombocytopenia and thrombosis. The HIT antibody positivity rate among patients who have been administered unfractionated heparin in the fields of general medicine and surgery is 8-17%, in which only about 0.2-3% actually develop thrombocytopenia or thrombosis. However, if appropriate treatment is not given,
thromboembolism will occur in 20-50% of cases, so rapid diagnosis and appropriate treatment are required for HIT.
*Reference: Diagnosis and treatment guidelines for heparin-induced thrombocytopenia. Japanese Journal of Thrombosis and Hemostasis, 2021; 32(6 ): 737-782 (Japanese only)
https://www.jsth.org/wordpress/wp-content/uploads/2015/04/ヘパリン起因性血小板減少症の診断・治療ガイドライン.pdf

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/.

FOLLOW US　

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.

Back to "News"