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Press Release
Sysmex Obtains Insurance Coverage for Its Immunoassay Reagent “HISCL™ M2BPGi™-Qt Assay Kit” for Quantitative Measurement of Hepatic Fibrosis Progression from Blood Samples
- Planned for Domestic Launch in February 2024, with Subsequent Introduction Overseas -
Sysmex Corporation (HQ: Kobe, Japan; President: Kaoru Asano) announced that its “HISCL M2BPGi-Qt Assay Kit” (“the Product”), which enables quantitative evaluation of hepatic fibrosis progression from blood in patients with chronic hepatitis and cirrhosis of the liver, has started to be covered by national health insurance in Japan from December 20, 2023. The Product will support the diagnosis of hepatic fibrosis stages based on more detailed test results, and contribute to early detection and treatment monitoring of diseases caused by chronic hepatitis. The Product is scheduled to be launched in Japan in February 2024.
With causes such as viral hepatitis, excessive alcohol consumption and non-alcoholic fatty liver disease (NAFLD1), chronic hepatitis is a state in which liver cells are destroyed, inducing chronic inflammation. When there is sustained damage to the liver, hepatic fibrosis occurs, and its progression may result in serious conditions such as cirrhosis of the liver and liver cell carcinoma. Therefore, in the diagnosis and therapeutic monitoring of diseases resulting from chronic hepatitis, assessment of the progression of hepatic fibrosis is highly important. However, diagnosis requires hospitalization and liver biopsy, which is highly invasive.
Although recent advances in treatment have made it possible to eradicate the hepatitis C virus with oral agents, liver cancer may occur even after the virus has been eliminated. Therefore, to identify patients at high risk of developing liver cell carcinoma and to facilitate early definitive diagnosis and treatment, there is an increasing need for highly reliable and minimally invasive tests that can easily monitor the progression of hepatic fibrosis.
Sysmex obtained manufacturing and marketing approval in Japan in December 2013, and approval for insurance coverage as of January 2015 for the HISCL M2BPGi Assay Kit,2 which evaluates the progression of hepatic fibrosis from blood by detecting the sugar chain structure of a protein that indicates the stage of hepatic fibrosis. This assay kit, one of Sysmex's unique parameters in the field of immunochemistry testing, has supported the diagnosis and treatment of chronic hepatitis and cirrhosis in numerous medical institutions as an innovative test that minimizes patient burden.
The “HISCL M2BPGi-Qt Assay Kit” received the manufacturing and marketing approval in Japan as an in vitro diagnostic on November 20, 2023, and national insurance coverage commenced from December 20, 2023. The Product represents the evolution of existing technology, changing the units of measurement result for identifying the disease state from the cut-off index (negative (-), positive (1+) or positive (2+))3 to the concentration of M2BPGi (AU/mL), thereby realizing a quantitative evaluation of hepatic fibrosis progression. This will support diagnosis of hepatic fibrosis progression based on more detailed test results and contribute to the early detection, follow-up observation, and post-treatment monitoring of diseases caused by chronic hepatitis. In addition, the use of quantitative data is expected to contribute to the creation of new clinical value in chronic hepatitis testing, such as studies on reference values for more appropriate evaluation of hepatic fibrosis stages of each disease and efficacy research on the determination of the risk of progression to liver cell carcinoma.
Going forward, Sysmex will first proceed with preparations aiming at a domestic launch in February 2024, and then plans to successively launch the Product in other countries.
Sysmex will continue to establish and promote the widespread use of high-value diagnostic technologies in Japan and overseas in order to improve people’s lifetime healthcare journey,4 supporting the universal desire of people to live long and healthy lives.
Product Overview
| Generic name |
Mac-2 Binding Protein (M2BP) Glycosylation isomer kit
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| Product name | HISCL™ M2BPGi™-Qt Assay Kit | |
| Registration number in Japan | 30500EZX00052000 | |
| Intended use |
Measurement of Mac-2 Binding Protein (M2BP) Glycosylation isomer in serum or plasma (support in diagnosing the progression of hepatic fibrosis)
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| NHI coverage in Japan | D007-48 Mac-2 Binding Protein Glycosylation Isomer 194 points (effective December 20, 2023) | |
| Manufactured and distributed by | Sysmex Corporation | |
| Target market | Japan |
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| Launch | February 2024 (scheduled) | |
References
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Press release dated December 26, 2013: “Sysmex Succeeds in World's First Practical Application of Technology Employing a Glycosylation Marker to Test Hepatic Fibrosis; Technology Allows the Degree of Hepatic Fibrosis, from Hepatitis to Cirrhosis of the Liver, to Be Determined Swiftly”
Press release dated January 5, 2015: “Hepatic fibrosis test reagent (HISCL M2BPGi Assay Kit) receives approval for health insurance coverage - Speedy blood sample-based test for measuring the progression of hepatic fibrosis from chronic hepatitis to cirrhosis of the liver -”
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Terminology
| 1 |
Following the announcement of the change in the names NAFLD and NASH (non-alcoholic steatohepatitis) to MASLD (metabolic dysfunction-associated steatotic liver disease) and MASH (metabolic dysfunction-associated steatohepatitis) by the relevant academic societies in Europe and the U.S., the Japan Society of Hepatology announced its endorsement of the name changes and classification. While the previous names are used in this press release, in line with future diagnosis guideline and other revisions, it is planned to use the names MASLD and MASH in future announcements.
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| 2 |
Generic name: Mac-2 Binding Protein (M2BP) Glycosylation isomer kit
Product name: HISCL™ M2BPGi™ Assay Kit
Registration number in Japan: 22500AMX01930000
Manufactured and distributed by: Sysmex Corporation
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| 3 | Cut-off index (COI): The COI is the relative value of luminescence intensity compared to a sample of a known concentration, indicating the amount of antibody (in this case the amount of M2BPGi) in a sample. In measurements using the existing HISCL M2BPGi Assay Kit, the COI is used to determine whether a sample is negative (-), positive (1+), or positive (2+). |
| 4 |
Sysmex is proposing the concept of a “healthcare journey.” We view the various healthcare-related events a person experiences throughout their lives (life stages), along with the corresponding process this involves (such as treatment at healthcare institutions), as a “journey”. Through various collaborations, we aim to offer new value to improve each individual’s healthcare journey, and to become an essential presence in society.
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About Sysmex Corporation
Sysmex Corporation, headquartered in Kobe, Japan, is a global leader in in vitro diagnostics. Since its establishment 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." To realize this vision, Sysmex identifies and verifies prioritized Sustainable Development Goals (SDGs) and materiality (priority issues), thereby maintaining its growth as a company that generates both social and economic value. 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 Corporation, 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.