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Sysmex obtains insurance coverage for HISCL™ M2BPGi™-Qt Assay Kit

Sysmex Corporation announced that its “HISCL M2BPGi-Qt Assay Kit”, 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  
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)  
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
Launch February 2024 (scheduled)

MB Bureau

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