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.
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 | |||
Name: |
ipsogen BCR-ABL1 Mbcr IS-MMR DX Kit |
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NHI points: |
2,520 |
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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 |
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http://www.sysmex.co.jp/en/corporate/news/2014/140812.html |
1 Translocation: |
A type of chromosomal aberration which occurs when part of a chromosome becomes separated and changes location to adhere to another chromosome. |
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2 Source: |
2011 Patient Survey, Ministry of Health, Labour and Welfare |
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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). |
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4 Practice guideline: |
Japanese Society of Hematology practice guidelines on hematopoietic malignancies (2013 edition) |
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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. |
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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. |