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 -
Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) announced today approval of a hepatic fibrosis test reagent (HISCL M2BPGi Assay Kit) for insurance coverage as of January 1, 2015.
This test reagent requires only a blood sample (serum) to determine within just 17 minutes at a diagnostic lab of a medical facility the status of progression of hepatic fibrosis from chronic hepatitis to Hepatic cirrhosis, which has been suspected to be a cause of hepatocellular carcinoma. It is expected that eligibility for insurance will increase the availability of non-invasive testing at a greater number of medical facilities, thus promoting the early detection of diseases arising from chronic hepatitis and easing the burden of therapeutic monitoring on patients.
Viral hepatitis is the most prevalent infectious disease in Japan, affecting some 3 million people. Left untreated, the condition can develop into severe illness as it progresses toward liver cell carcinoma. According to cancer statistics compiled by the National Cancer Center, in 2011 as many as 31,800 deaths resulted in Japan from liver cell carcinoma, and liver cancer ranked as the fourth most prevalent type of cancer, following lung cancer, stomach cancer and colon cancer. According to WHO data, worldwide roughly 400 million are infected, with around 1.4 million deaths in 2010, marking viral hepatitis as a serious infectious disease of global dimensions.
As chronic hepatitis advances toward liver cell carcinoma, the amount of fiber-rich tissue in the liver increases and hepatic function gradually declines. Determining the degree of hepatic fibrosis is an important part of the treatment process for viral chronic hepatitis. The typical testing process involves taking a biopsy of the liver tissue (living tissue diagnosis), requiring a patient to be hospitalized because of its high invasiveness. This places a substantial burden on the patient on both the physical and economic fronts.
Sysmex has developed a reagent for testing the degree of viral hepatitis-induced disease (hepatic fibrosis) during blood testing, developed in cooperation with the former Research Center for Medical Glycoscience (the former Director: Hisashi Narimatsu) of the National Institute of Advanced Industrial Science and Technology, or AIST (Tsukuba HQ: Tsukuba, Ibaraki Prefecture, Japan; President: Ryoji Chubachi), building on the successes of New Energy and Industrial Technology Development Organization, or NEDO (HQ: Kawasaki, Kanagawa Prefecture, Japan; Chairman: Kazuo Furukawa) projects. This reagent received manufacturing and marketing approval on December 10, 2013. Sysmex has succeeded in world's first practical application of technology employing a glycosylation marker* to test hepatic fibrosis.
Dated January 1, 2015, the hepatic fibrosis test reagent was recently approved for insurance coverage.
Usage of the test reagent with the Sysmex HISCL-Series (HISCL-5000/2000i/800) of automated immunoassay systems requires only a blood sample to determine within just about 17 minutes the status of progression of hepatic fibrosis to chronic hepatitis and cirrhosis of the liver, which has been suspected to be a cause of hepatocellular carcinoma. It is expected that eligibility for insurance will increase the availability of testing requiring only a blood sample at a greater number of medical facilities, thus promoting the early detection of diseases arising from chronic hepatitis and easing the burden of therapeutic monitoring on patients.
The product will be introduced to the domestic market with the focus on medical facilities and diagnostic centers. Introductions to Asian countries, specifically China with its large number of liver disease patients, will follow in order.
Going forward, Sysmex aims to reduce the burden on patients and enhance the quality of testing, as well as instilling its customers with confidence.
|Details of insurance coverage|
Mac-2 Binding Protein (M2BP) Glycosylation isomer
|Medical Fee Points:||
D215-2 Liver stiffness measurement 200
|Outline of Mac-2 Binding Protein (M2BP) Glycosylation isomer|
|Measuring method:||Chemiluminescent enzyme-linked immunoassay using a two-step sandwich method|
|Content of measurement:||Measurement of Mac-2 Binding Protein (M2BP) Glycosylation isomer in the serum
(Support in diagnosing the progression of hepatic fibrosis)
|Efficacy:||For use with respect to diagnosis and treatment of chronic hepatitis in support of assessment of the stage of hepatic fibrosis, indication of therapeutic regimen, and therapeutic monitoring.|
|Information for reference:|
Released as of December 26, 2013
|Sugar chain, glycosylation marker: Sugar chains, the linked monosaccharides that link to the surface of a cell or a protein, are sometimes described as "cell and protein costumes." Their roles include the transmission of information specific to individual cells and intercellular communications. A glycosylation marker is a biomarker that targets structural changes in sugar changes present in glycoproteins.