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Sysmex Corporation (HQ: Kobe, Japan; President: Hisashi Ietsugu) announced today the launch of five diagnostics reagents for its fully automated immunoassay analyzer HISCL-2000i, which was released in October 2007. The first of this series, the HISCL PSA Assay Kit for prostate cancer tumor markers will be launched in late May of this year, followed in June by the HISCL AFP Assay Kit for liver cancer tumor markers, the HISCL CEA Assay Kit for colon cancer and other digestive system cancer tumor markers, and the HISCL HBeAg Assay Kit and HISCL Anti-HBe Assay Kit for hepatitis B.
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As a way of measuring proteins, etc., immunochemistry testing has a wide range of applications, from diagnosis of infectious diseases, cancers, heart diseases, and autoimmune diseases, to their course of treatment. As such, immunochemistry testing plays an essential role in the early detection of diseases and determination of therapeutic effects. The annual worldwide market for immunochemistry testing reportedly amounts to approximately 820 billion yen, or a quarter of the entire diagnostics market. In Japan, the immunochemistry testing market is estimated at over 150 billion yen, or about 40% of the entire diagnostics market.
In a bid to establish our presence in the immunochemistry market, Sysmex released the fully automated immunoassay analyzer HISCL-2000i in October 2007, as well as reagents for infectious diseases such as hepatitis B, hepatitis C, and HIV, and those for the detection of thyroid hormone markers, which can serve as an indicator for Basedow's disease, etc. With the aim of expanding our offering of measurement items, our R&D team is working on the development of reagents for detection of diseases (tumor markers, heart diseases, etc.) and coagulation molecular markers. In order to expedite the development of these reagents, we are also working closely with our partner companies. At present, Sysmex is involved in the joint development of reagents for tumor markers, which are useful in the early diagnosis and treatment of cancer, with Kainos Laboratories, Inc. (HQ: Tokyo, Japan; President:Toshimichi Nakamura). The HISCL PSA Assay Kit for prostate cancer tumor markers is the first offering which resulted from such joint efforts, and will be followed by the HISCL AFP Assay Kit for liver cancer tumor markers and the HISCL CEA Assay Kit for digestive system cancer tumor markers in June. In the area of infectious diseases, Sysmex is teaming up with Japan Lyophilization Laboratory (HQ: Tokyo, Japan; President:Noboru Hagiwara) for the joint development of diagnostics reagents. The two companies are planning to release two types of hepatitis B diagnosis aids, the HISCL HBeAG Assay Kit and HISCL Anti-HBe Assay Kit, also in June of this year. With a view towards expanding its range of diagnostics reagents up to forty items, Sysmex will accelerate its R&D efforts both in-house and through partnerships.
Going forward, we intend to augment our range of available reagents in the diagnostics field, and render our services so that we may achieve qualitative improvement and greater efficiency in immunochemistry testing, thereby enhancing people's quality of life (QOL) while at the same time increasing our share in the immunochemistry testing market.
| Product name: |
Fully automated immunoassay analyzer HISCL-2000i |
| Target market: |
Japan |
| Product details: |
(1) |
Processing capacity: 180 tests per hour |
| (2) |
Target facilities: medium- to large-scale facilities performing between 100 and 300 tests per day |
| (3) |
Optional service: Ability to receive online support and make use of remote quality control services through connection with the Sysmex Network Communication Systems(SNCS), our network support product |
[About the product]
|
Product name |
HISCL PSA Assay Kit |
HISCL AFP Assay Kit |
HISCL CEA Assay Kit |
HISCL HBeAg Assay Kit |
HISCL Anti-HBe Assay Kit |
|
Target market |
Japan |
Japan |
Japan |
Japan |
Japan |
|
Release date |
Late May |
Late June |
Late June |
Mid June |
Mid June |
|
Packaging (per package) |
100 tests |
100 tests |
100 tests |
50 tests |
50 tests | |
About Kainos Laboratories, Inc. Headquartered in Bunkyo-ku, Tokyo, Kainos Laboratories, Inc. is engaged in the development, manufacture, marketing, and import/export of pharmaceuticals, in vitro diagnostics, chemical products, and physical and chemical measuring instruments. Further information can be found by visiting http://www.kainos.co.jp/eng/.
About Japan Lyophilization Laboratory Based in Bunkyo-ku, Tokyo, Japan Lyophilization Laboratory is involved in the manufacture, contract lyophilization, and marketing of in vitro diagnostics, lactobacillus preparations, and health food, etc. Further information can be found by visiting http://www.bcg.gr.jp/nitto/.
- <Glossary>
- PSA (Prostate specific antigen):
- A glycoprotein specifically manufactured and secreted by the prostate epithelial cells
- CEA (Carcinoembryonic antigen):
- A protein that is present only in fetal cells of the digestive system. Also produced among tissues in which cancer cells have multiplied.
- AFP (α-fetoprotein):
- A glycoprotein that is found in fetal serum. AFP levels become undetectable after birth, but begin to elevate with the development of liver cancer.
- HBeAg・HBeAb:
- HBeAg, or the hepatitis B e-antigen, is a protein which forms part of a core (core particle) of the hepatitis B virus (HBV). It is produced excessively when HBV replicates in liver cells, and is discharged into the blood as a soluble protein (which does not form HBV particles). A positive reaction during an HBeAg test indicates that HBV has replicated rapidly and has reached a highly infectious level.
HBeAb stands for hepatitis B e-antibody. A positive reaction during an HBeAb test indicates that HBV replication has become mild and that HBV is at a low infectious level.
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