October 3, 2007

   

Notice of Launching Urine Tumor Marker Assay Kit


 

We hereby announce that TRANS GENIC INC. (hereinafter referred to as q‡weqˆ) released Urinary Diacetylspermidine ELISA Kit developed by GANP®Mouse Technology (*1) as a research reagent on October 3, 2007.


Polyamines (*2) excreted in urine have attracted attention since they are considered to be used as tumor markers (*3). We have especially focused on diacetylspermine and diacetylspermidine among them in our research and development for assay system using specific antibodies.

Regarding diacetylspermidine, it has been difficult to produce specific antibodies with conventional methods, but we are successfully producing highly specific antibodies using GANP®Mouse Technology. (Open patent number: 2006-106992)

We have recently succeeded in developing an assay system using the antibody and prepared to release it as an assay kit.

q_q_The following is the summary of the launch of the kit.

Product Name
Urinary Diacetylspermidine ELISA Kit (Code KK123)
Specification
80 assays
Price
105,000 yen (consumption tax included)
Distribution method
Sold through our distributing agents

Cosmo Bio Co., Ltd.,
Funakoshi Corporation,
Wako Pure Chemical Industries, Ltd.
Annual Sales Prospect
50 - 100 kits

Characteristics and practicality of this product and usefulness of the product as a urine tumor marker were presented by TRANS GENIC and Dr. Seiji Hosaka of National Hospital Organization Kumamoto Medical Center, respectively, at the 66th Annual Meeting of the Japanese Cancer Association on October 3, 2007. (*4)

Regarding diacetylspermine whose assay kit has already been on the market, we have onerously provided several diagnostic reagent manufacturers with the monoclonal antibody and licensed the patent (patent number: 3816512). They are now developing diagnostic regents utilizing the antibody.

Besides developing diagnostic reagents, we are distributing antibodies and ELISA kits as research reagents to support advancement of life-science such as researches on proteins and identification of causes of various diseases. We will continuously make our efforts to develop new antibody reagents utilizing our unique GANP®Mouse Technology and DNA immunization (*5) in order to enhance our product lineups in the area of cancer and metabolic syndrome.

The effects of the launch of the product on our business performance are as yet unknown, but we will make an announcement as soon as it is revealed to have a significant impact on our future performance.

Reference:

Overview of business using GANP®Mouse Technology (*1)

qÎ. Commercialization (as of the end of August, 2007)
1-1
Number of research reagents launched: 4
1-2
Number of licensing we have granted for developing diagnostic reagents: 3
 
qÏ. Number of custom production service of antibodies: 62 (as of the end of August, 2007)
   

Overview of development of tumor marker using urine

qÎ. Diacetylspermine
1-1
q‡Urinary Diacetylspermine ELISA Kitqˆ was released as a research reagent in October, 2003.

1-2
Usefulness of diacetylspermine to develop diagnostic reagents has been examined by several diagnostic reagent manufacturers. We have licensed one of them.
 
qÏ. Diacetylspermidine
2-1
q‡Urinary Diacetylspermidine ELISA Kitqˆ was released as a research reagent in October, 2007.

Note:

*1

GANP®Mouse Technology

This is our unique technology to produce antibodies using q‡GANP® miceqˆ, genetically engineered mice whose GANP gene expression is increased. Compared to conventional methods of antibody production, GANP®Mouse Technology can produce higher-affinity and higher-specificity antibodies with a higher success rate. Therefore it is considered that the technology has many advantages in applying it to development of diagnostic reagents and pharmaceuticals.
We regard it as a fundamental technology in our antibody-related technological platforms and promote various businesses utilizing it. For example, we are developing our original products, offering custom production services and granting its license to pharmaceutical companies and diagnostic reagent manufacturers to gain profits from its licensing fees and product royalties.

- What is GANP (Germinal Center Associated Nuclear Protein)?
It is a new nuclear factor increasingly expressed in germinal-center B cells. Dr. Nobuo Sakaguchi of Kumamoto University discovered it.

- What are characteristics of GANP®mice?
Expression of GANP genes in germinal-center B cells is more increased in GANP mice than in normal mice. These GANP proteins cause the genetic alteration of the V regions with increased mutations. Therefore high-affinity and high-specificity antibodies can be produced with a high success rate.


Sakaguchi N. et al., J Immunol. 2005 Apr 15;174(8):4485-94.

 

*2

Polyamine

They are substances considered to play an important role in the process of cell growth and control. After finished playing the role, they are excreted from cells and eventually in urine.

 

*3

Tumor Markers

They are substances detected in body fluids such as blood and urine, or tissues in response to cancer growth.

 

*4

Topics presented at the 66th Annual Meeting of the Japanese Cancer Association

> q‡Developing a competitive ELISA method using a highly specific antibody for N1 and N8-diacetylspermidine as a new tumor marker in urineqˆ

Shingo Shinagawa 1, Hiroshi Nose 1, Akemi Matsuoka 1, Junko Kono 1, Seiji Hosaka 2
(1 TRANS GENIC INC., 2 Surgical Department, National Hospital Organization Kumamoto Medical Center)

>q‡Confirming usefulness of diacetylspermidine (DiAcSpd) in urine as markers of various tumors using a new ELISA kitqˆ

Seiji Hosaka 1, Shingo Shinagawa 2, Hiroshi Nose 2, Akemi Matsuoka 2, Junko Kono 2, Kenichiro Yamamoto 1, Naoya Yoshida 1, Shinichiro Tanaka 1, Masaharu Odo 1, Takashi Kurisaki 1,
Yasuharu Nishimura 3 , Shigeru Katafuchi 1, Satoshi Ikei 1
(1 Surgical Department, National Hospital Organization Kumamoto Medical Center, 2 TRANS GENIC INC., 3 Department of Immunogenetics, Faculty of Medical and Pharmaceutical Sciences, Kumamoto University)

 

*5

DNA immunization

Unlike a commonly practiced antibody production method in which protein or peptides are used as antigens, expression vectors which encode objective proteins are directly injected in animals in DNA immunization. Therefore, the antigens easily retain their original structures in vivo, enabling us to produce antibodies which have been difficult to produce by conventional methods, such as an antibody which recognizes membrane proteins.

 


 
 
 

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