Press Release

Insurance Coverage for Sysmex's Reagent to Monitor Therapeutic Gains on Chronic Myelogenous Leukemia (CML) (ipsogen BCR-ABL1 Mbcr IS-MMR DX Kit)

  Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) announced today that its reagent (ipsogen BCR-ABL1 Mbcr IS-MMR DX Kit) to monitor therapeutic gains on CML, reporting on the International Scale (IS), has been approved for insurance coverage as of April 1, 2015.

  CML is a disease that occurs as the result of a reciprocal translocation1 between chromosomes 9 and 22 in a blood cell, causing the BCR-ABL1 gene to be generated and leading to uncontrolled cell propagation. CML patients in Japan number approximately 11,0002, and that figure is said to be on the rise.
  To treat CML, a molecularly-targeted drug3 targeting the BCR-ABL1 protein went on sale in 2001, and therapeutic efficacy has been improving since that time.
  A second-generation molecularlytargeted drug with even higher therapeutic efficacy has now been developed and introduced into the market.

  Monitoring of the therapeutic gains of a molecularlytargeted drug based on International Scale values (Major BCR-ABL mRNA IS) established by practice guidelines4 using a quantitative RT-PCR reagent5 (ipsogen BCR-ABL1 Mbcr IS-MMR DX Kit) was approved for insurance coverage on April 1, 2015.

  This reagent, which includes a calibrator using values based on WHO International Standard products, monitors therapeutic gains on CML, making it a breakthrough reagent in its ability to convert to International Scale values. As to measurement sensitivity, the reagent ensures a level that allows stable confirmation of MR4.56.
  As a result, the reagent enables accurate and highly sensitive monitoring of therapeutic gains on CML, leading to a better patient quality of life (QOL) and advances in healthcare.

  Going forward, Sysmex will promote the introduction of this reagent in the Japanese market, focusing on medical institutions and commercial laboratories.
  In addition to screening tests in the hematology field, Sysmex works to improve patient QOL in testing during therapy. We aim to contribute to the standardization and development of healthcare and instilling patients with confidence.


New Product Overview



ipsogen BCR-ABL1 Mbcr IS-MMR DX Kit

  NHI points:  


  Measurement scope:   Major BCR-ABL mRNA: 3-1,000,000copies/assay
ABL mRNA: 1,000-1,000,000copies/assay


Information for reference:

Released as of August 12, 2014
"Sysmex Receives MHLW Approval to Manufacture and Market Reagent to Monitor Therapeutic Gains on Chronic Myelogenous Leukemia (CML), Japan's First to Report on the International Scale (IS)"


1 Translocation:


A type of chromosomal aberration which occurs when part of a chromosome becomes separated and changes location to adhere to another chromosome.

2 Source:  

2011 Patient Survey, Ministry of Health, Labour and Welfare

3 Molecularly-targeted drug:  

A drug created to target only certain types of molecules (proteins). Most such drugs are developed and marketed in the field of cancer and are used to control activity of the protein responsible for tumorigenic transformation (in this case, the BCR-ABL1 protein).

4 Practice guideline:  

Japanese Society of Hematology practice guidelines on hematopoietic malignancies (2013 edition)

5 Quantitative RT-PCR reagent:  

A reagent that determines with a high degree of sensitivity the quantity of specific genes that are generated. Used in conjunction with a quantitative PCR instrument.

6 MR4.5:  

A state in which the number of CML cells within a patient's body have fallen to a lower level than at the onset of CML, dropping to a value of 0.0032% or less on the International Scale. Many clinical studies use MR4.5 as the standard for withdrawing molecularly-targeted drugs.

  • Information contained in the press release is current as of the date of the announcement,
    but may be subject to change without prior notice.

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