The Biomedical Group of Takara Shuzo Co., Ltd. and Arkray Inc. have signed the agreement that both parties cooperate to develop a new, diagnostic system using ICAN method, that is an innovative isothermal DNA amplification technology developed by scientists of the Biomedical Group. The goal of this collaboration is to develop a diagnostic system for point-of-care testing (POCT) that can serve immediate reports of diagnosis in a hospital.

ICAN method (Isothermal and Chimeric primer-initiated Amplification of Nucleic Acids) provides an alternative procedure to detect a very small amount of target DNA in a sample with efficiency equivalent to or higher than PCR (Polymerase Chain Reaction) method. Arkray intends to seek a new field in the diagnostics business and to add new diagnostic products based on the nucleic acid technology to its blood analyzers and urine analyzers for diabetes and others.

Under the terms of the agreement, Takara Biomedical Group grants Arkray the non-exclusive rights to use ICAN technology in the development of devices for clinical diagnosis, food testing, and genetic examination in human. The Group will develop reagents such as chimeric primers and enzymes for the diagnostic systems, and Arkray will do a device and reagent kits for specific purposes. Arkray will also operate clinical evaluation trials and applications for governmental approvals of the diagnostics. The term of cooperation is 5 years, and within 2 years from the beginning the parties will firstly develop diagnostic systems for infections such as hepatitis virus, human immunodeficiency virus, and Mycobacterium tuberculosis. After that, additional diagnostic items will be developed in the field of food testing and the genetic examination. Arkray can exclusively distribute the systems for nucleic acid detection developed by the collaboration in Japan, and both parties have co-exclusive distribution rights for foreign markets. The market of diagnostics for infections is estimated at ¥40 billion on the worldwide basis and at ¥7 billion in Japan. At present, POCT system for infections is not realized due to requirements of specific techniques and heavy investment. Both parties hope to acquire more than 20% of annual sales in diagnostics based on nucleic acid technologies by distributing a practical system for POCT in the next 5 years.