[By NBC-1TV H. J Yook]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.”