Highly Sensitive Immunological
Assay System for Cancer Diagnosis Using Urine Samples: The
Development of In Vitro Diagnostic Products
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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.
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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.
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The
potential influence of the agreement on our future business
performance remains uncertain. |
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(*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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