Kyoto, Japan, January 30, 2003-Takara Bio will release on February 24th a gene test reagent for detecting duplication mutations (ITD mutations) of FLT3 genes, the cause of refractory leukemia. FLT3/ITD mutation is associated with poor response to therapy of leukemia and found in one third of acute myelogenous leukemia patients. The mutation was discovered by Shohei Yokota, M.D., Ph.D. at the 3rd Internal Medicine division of Kyoto Prefectural University of Medicine, and Takara Bio has applied for the related patents.

Following on the heels of this discovery has been a worldwide movement towards the development of molecule-targeted medicines that inhibit FLT3. The new test reagent will not only be useful for measuring efficacy of the treatment but also for testing the applicability of the molecule-targeted medicines.

The test reagent detects mutation of the genes by measuring the increase in length of a gene caused by FLT3/ITD mutation. In the protocol, nucleic acid taken from bone marrow or blood is used as the specimen, the area of mutation is amplified by PCR method using the test reagents, and the length of the amplified products is measured by electrophoresis or DNA chip. The test reagent is sensitive enough to screen accurately for refractory leukemia and the test can be completed in about two hours. Each patient has different FLT3/ITD mutation patterns. Each mutation fragment amplified by PCR can be used to design primers for Real Time PCR after sequencing. It enables the sensitive detection of remaining leukemia cells and the personalized treatments for each individual patient.

The FLT3 kinase specific inhibitor has been developed and clinically tested as a molecule targeted medicine for refractory leukemia. Takara Bio will release the FLT3/ITD Mutation Detection Set for R&D and clinical testing.

Summary of the Product
Name of Product : TaKaRa FLT3/ITD Mutation Detection Set
(test reagent for research purposes) targeted for 50 reactions
Production and Distribution : Takara Bio Inc.

About Takara Bio Inc.
Takara Bio Inc. is an innovative biotechnology company based in Shiga, Japan. As a world leader in biotechnology research and development, Takara Bio was the first company to market PCR technology in Japan and is also the developer of the RetroNectin™ reagent, which is a world-standard in gene therapy protocols. In addition to providing research reagents and equipment to the life science research market, Takara Bio has active research and product development activities in the fields of gene and cell-based therapy, and agricultural biotechnology; and is committed preventing disease and improving the quality of life for all people through the use of biotechnology. Through strategic alliances with other industry leaders, the Company aims to extend its reach around the world. More information is available at http://www.takara-bio.com.

For more information:
Corporate Communications
Takara Bio Inc.
E-mail: bio-ir@takara-bio.co.jp

This article is translated from press release in Japanese for your convenience.

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