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Aug. 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)

  Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) has received manufacturing and marketing approval for a reagent that monitors therapeutic gains for chronic myelogenous leukemia (CML). This reagent (ipsogen BCR-ABL1 Mbcr IS-MMR DX Kit) will be the first to be released in the Japanese market that reports on the International Scale (IS) for BCR-ABL1 testing. Moving forward, Sysmex will introduce the reagent in the Japanese market to help provide a more accurate diagnosis for CML patients.

  Chronic myelogenous leukemia (CML) is a disease that occurs as the result of a reciprocal translocation1 between chromosomes 9 and 22 on a blood cell, causing the BCR-ABL1 gene to be generated and leading to uncontrolled cell propagation.
  In 2011, CML patients in Japan numbered 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 molecularly targeted drug with even higher therapeutic efficacy has now been developed and introduced into the market.
  Accurately monitoring the therapeutic gains achieved by a molecularly targeted drug, which is a type of cancer treatment, requires a test to measure the minimum residual disease (MRD)4 remaining in the blood. The BCR-ABL1 mRNA genetic test is gaining global prevalence as a testing method.

  Compared with other types of test, the data variance in genetic test can be large, depending on the measurement method applied. Particularly for the BCR-ABL1 mRNA test, efforts are being made to promote IS so that test measurement values across laboratories can be standardized. In Japan, the practice guideline on hematopoietic malignancies (2013 edition) created by the Japanese Society of Hematology recommends using the BCR-ABL1 mRNA test in conjunction with the IS to monitor the therapeutic efficacy of CML.
  However, no BCR-ABL1 mRNA diagnostic reagent had been approved in Japan that could report on the IS, so expectations were mounting about the emergence of a reagent that could be used to perform treatment in accordance with the guideline.

  To address this issue, Sysmex introduced a quantitative RT-PCR reagent5 for BCR-ABL1 mRNA from QIAGEN Marseille, conducted clinical evaluation tests, and obtained manufacturing and marketing approval as the first Japanese CML reagent for monitoring therapeutic gains capable of IS reporting (ipsogen BCR-ABL1 Mbcr IS-MMR DX Kit).
  As a result, it is now possible to monitor therapeutic gains in accordance with the guidelines and provide more accurate diagnosis for CML patients, leading to better patient quality of life (QOL) and advances in healthcare.

  In addition to screening tests in the hematology field, Sysmex works to provide clinical value for treatment and monitoring in its aim to contribute to improved patient QOL and the standardization and development of healthcare.

New Product Overview
Name:

ipsogen BCR-ABL1 Mbcr IS-MMR DX Kit

Launch:

Early September, 2014 (expected)

Target market: Japan
Target facilities: Clinical testing centers, university hospitals, flagship hospitals, others
NHI points: To be determined
 

 
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 Minimum residual disease: Small number of tumor cells that remain in the body after treatment commences, even if the disease is in remission.
5 Quantitative RT-PCR reagent: A reagent that determines the quantity of specific genes that are generated to a high degree of sensitivity. Used in conjunction with a quantitative PCR instrument.







*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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