Takara Bio Grants Patent License to Invivoscribe Technologies for FLT3-ITD Testing in Japan

SAN DIEGO, CA--(Marketwire - Dec 5, 2012) - Invivoscribe Technologies, Inc. (San Diego, California) announced today that it has entered into an agreement with Takara Bio, Inc. (Otsu, Shiga, Japan) under which it has been granted a series of licenses to facilitate and conduct patent covered tests for the presence of internal tandem duplication (ITD) mutations in the FLT3 gene.

FLT3-ITD mutations (also known as length mutations, FLT3-LM) 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 development of drugs effective for patients having the FLT3-ITD mutation are in clinical trials worldwide. 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.

In 2006 Takara Bio granted Invivoscribe an exclusive worldwide license (excluding Japan) to use the patent covering detection method of FLT3-ITD mutations. Under the new agreement, Invivoscribe obtains several licenses, including an exclusive license to produce and sell in vitro diagnostic (IVD) products for FLT3-ITD detection in Japan; a sole license to produce and sell research reagent products for FLT3-ITD detection in Japan (now with Takara); and, a license to directly provide testing services for FLT3-ITD detection.

Dr. Jeffrey Miller, founder and CEO of Invivoscribe, comments, "We are excited about entering the Japanese market for FLT3 testing. This agreement augments our dominant intellectual property position in the FLT3 testing area, in particular for internal tandem duplication detection. We believe that Takara's decision to expand its relationship with Invivoscribe makes sense for everyone involved. Development and regulatory clearance of IVD products and companion diagnostics has been promoted by unifying the license rights for the Japanese market with other worldwide rights Invivoscribe had previously secured. This will promote harmonized testing for this clinically important biomarker."

About Invivoscribe:

Invivoscribe Technologies, Inc., a privately held life science 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. Invivoscribe 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 for their patients.

Invivoscribe manufactures its products within its GMP facility in San Diego, California. The majority of Invivoscribe's products are patent protected. Invivoscribe's products are currently sold to clinical laboratories in over 50 countries 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.

About Takara Bio:

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 to preventing disease and improving the quality of life for all people through the use of biotechnology. Through strategic alliances with other industry leaders, Takara Bio aims to extend its reach around the world. More information is available at http://www.takara-bio.com.