April 18, 2005

   

Highly Sensitive Immunological Assay System for Cancer Diagnosis Using Urine Samples: The Development of In Vitro Diagnostic Products


 

We hereby announce that TRANS GENIC INC. (hereinafter referred to as q‡weqˆ) and a diagnostic reagent manufacturer on April 18, 2005, agreed to advance clinical development of in vitro diagnostic reagents used for cancer diagnosis using urine samples and to apply for manufacturing approval, since anti-diacetylspermine antibody (*1) onerously provided by us had shown favorable results in preliminary examinations conducted by the company.

Although a wide range of blood tumor markers has been commonly used in various carcinoma diagnosis, non-invasive diagnostic methods (*2) with simple procedures and of high specificity for early stage cancers are still in demand. Responding to this, we carried out researches to establish an assay system for cancer diagnosis using urine samples, and then, applied for a patent on a highly sensitive immunological assay system that can be used for carcinoma diagnosis by urine samples, on January 24, 2005. We are now providing several diagnostic reagent manufacturers with anti-diacetylspermine antibody, the constituent feature of the patent, and they are considering developing in vitro diagnostic reagents utilizing the antibody.

Recently one of these companies which had conducted preliminary examinations since January 2005 saw favorable results in their assay system. Therefore we have agreed with the company to proceed with clinical development of the reagents and to ask for manufacturing approval and concluded q‡the contract on development of assay reagents for diacetylspermine in urineqˆ on April 18, 2005. This contract specifies that we shall onerously supply the company with the antibody, necessary for clinical development and production of in vitro diagnostic reagents continuously after they are launched on the market, while we shall receive royalties when the company actually produces and distributes the reagents. We intend to create the same business framework with other diagnostic reagent manufacturers.

The potential influence of the agreement on our future business performance remains uncertain.

 

(*1) The amount of polyamines secreted in urine has been considered to be closely related to cancer. Several researches have recently revealed that the amount of diacetylspermine, a kind of polyamines, secreted in urine is particularly linked to cancer, compared to other polyamines.

(*2) Unlike diagnoses based on the drawing of blood etc., non-invasive diagnostic methods based on manq†s natural physiological phenomena such as urine enables us to diagnose without considering any unwanted extracorporeal impact that could affect diagnostic results.

 
 
 

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