Takara Bio Inc. today announced that it entered into an agreement with Invivoscribe Technologies, Inc. (San Diego, California) to grant Invivoscribe Technologies licenses to facilitate and conduct patent covered tests for the presence of internal tandem duplication (ITD) mutations in the FLT3 gene.


FLT3 ITD mutations constitute an important known marker for refractory acute myeloid leukemia (AML). These mutations are detected in approximately one third of AML patients, and correlate with poor prognoses.
Clinical developments of drugs effective for patients having the FLT3/ITD mutation are actively conducted over the world. By testing for the presence of FLT3/ITD mutations, patients who are qualified for administration of FLT3-targeted drugs can be identified, resulting in more accurate and clinically effective treatment.


Takara Bio granted an exclusive worldwide (excluding Japan) license to Invivoscribe Technologies in July, 2006 to use the patent covering detection method of FLT3/ITD mutation. Under the agreement announced today, Invivoscribe Technologies obtains Japanese licenses 1) to produce and sell in vitro diagnostic (IVD) products for FLT3/ITD detection exclusively, 2) to provide testing services for FLT3/ITD detection non-exclusively, and 3) to produce and sell research reagent products for FLT3/ITD detection co-exclusively with Takara Bio.


Invivoscribe Technologies is offering research reagent products and testing services for FLT3/ITD detection mainly in US and Europe, and these products and services will be available in Japan under the Japanese licenses. Takara Bio also expects that development of the IVD product, including companion diagnostics, will be promoted by unifying the Japan and the rest of the world licenses.


[ 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.


[ About Invivoscribe Technologies ]

Invivoscribe Technologies, Inc.(TM), a privately held company, is a world leading provider of PCR-based molecular reagents, CE-marked IVDs, Analyte Specific Reagents, and RUO testing products and controls targeting the fields of hematology-oncology and hematopathology. IVS and its subsidiaries provide worldwide access to clinically validated, personalized molecular diagnostic products, which are used to identify, classify and monitor leukemias, lymphomas and other lymphoproliferative diseases. Results from these molecular tests enable doctors to determine and recommend the most successful method of treatment to their patients with cancer.
Invivoscribe manufactures their products in San Diego, CA, at their GMP facility. The majority of Invivoscribe’s products are protected by exclusive licensed patents. IVS products are currently sold in over 50 countries to clinical laboratories directly from Invivoscribe (USA) and Invivoscribe SARL (France), as well as through a network of distributors worldwide. For more information, please visit http://www.invivoscribe.com.