The Bio Research Institute of Takara Bio Inc. (President: Ikunoshin Kato) has developed a new method (Takara Bio LAM-PCR method) that has overcome deficiency in the LAM (Linear Amplification-Mediated)-PCR method used for monitoring the existence and insertion site of gene transduction cells within the patient's body after receiving gene therapy using retroviral vectors. Details of the new method will be announced on September 26 at the Japanese Cancer Association's general assembly, to be held in Nagoya from September 25.

Takara Bio's approach to gene therapy
We position the development and commercialization of gene therapy technology as an important strategic business. In collaboration with Indiana University, we are currently putting much effort into the development of the "RetroNectin^® method", a method that uses recombinant human fibronectin to remarkably improve the efficiency of retrovirus mediated gene transduction into hematopoietic stem cells, while in collaboration with Italy's gene therapy company MolMed S.p.A., we are developing the gene therapy for hematopoietic organ tumors in Asia and Far East Russia. The "RetroNectin^® method" is being used in stem cell gene therapy clinical research at more than 30 research institutes and hospitals worldwide, and has become the world standard method for gene therapy using retroviral vectors.

LAM-PCR method developed for monitoring the gene insertion site in gene therapy
In retroviral vectors mediated gene therapy, gene insertion is not limited to a specific site on the genome. This is due to the nature of retroviruses. Thus, some researchers are concerned that abnormalities in the gene transduction cell may occur due to insertion sites.

As a measure against such concern, the LAM-PCR method, used for monitoring the existence and insertion site of the gene transduction clone was developed.

However, it became clear that when using the existing LAM-PCR method (conventional method), if the transduced cells are few, heterogeneous and biased amplification occurs, and only the gene fragments from specific clones among the many clones are amplified. That is, although gene insertion is occurring at other genome sites, it appears that only those gene fragments prone to amplification are actually amplified. Thus, there is a risk that the composition of gene transduction cells may be improperly judged. Therefore, when many gene transduction clones exist in small amounts, this method cannot reflect the composition and amplify equally: it may be called a defective amplification method.

Takara Bio LAM-PCR method
Aiming at avoiding heterogeneous amplification, or improving the detection sensitivity and reproducibility, we improved the LAM-PCR method and developed the Takara Bio LAM-PCR method, which is superior to the conventional method.

With the Takara Bio LAM-PCR method, (1) when several types of gene transduction clone DNA exist; (2) when many gene transduction clone DNA exist; or (3) when a specific clone DNA dominantly exists, amplification reflecting each clone existence state was verified. Also, even when small amounts of various gene transduction clone DNA exist as templates, heterogeneous amplification does not occur with the Takara Bio method to the extent that it does with the conventional method. It became clear that gene amplification reflects the clone composition in Takara's method. Furthermore, the Takara Bio LAM-PCR method has been demonstrated to be superior in sensitivity and reproducibility compared to the conventional method.

Takara Bio LAM-PCR method, enables accurate monitoring of gene transduction site monitoring accuracy may be anticipated.

From now on, we shall effectively utilize this Takara Bio method for monitoring gene therapy in progress at our company. We plan to launch a research kit so that the method may be used effectively at gene therapy research sites as well.

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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