Fujirebio Obtains Manufacturing and Sales Approval for Cancer Gene Testing System 'Fujinokuni HOPE OncoPanel'

SRL Inc. (Headquarters: Minato-ku, Tokyo; President: Makoto Matsumoto; hereinafter 'SRL'), Shizuoka Cancer Center (Location: Nagaizumi-cho, Sunto-gun, Shizuoka; President: Katsuhiko Uesaka), SRL-Shizuoka Cancer Center Joint Inspection Organization Co., Ltd. (Headquarters: within Shizuoka Cancer Center Research Institute), and Fujirebio Inc. (Headquarters: Minato-ku, Tokyo; President: Takeshi Fujita) announced that they obtained manufacturing and sales approval from the Ministry of Health, Labour and Welfare on March 24, 2026, for the gene mutation analysis program (for cancer genome profiling tests) 'Fujinokuni HOPE OncoPanel' (hereinafter 'the System'), which was jointly developed by the four parties. This is the first medical device program for which the H.U. Group has obtained manufacturing and sales approval.

The System is one of the achievements of 'Project HOPE (High-tech Omics-based Patient Evaluation),' a joint research project between Shizuoka Cancer Center and SRL, and is the only one in Japan developed based on data from Japanese cancer patients (5,143 cases). The System performs matched-pair analysis comparing tumor tissue and blood from the same patient to analyze changes in 410 types of cancer-related genes and drug metabolism enzyme-related genes. By acquiring this information collectively, it can assist in diagnosing cancer and determining treatment plans.

The System obtained approval with the cooperation of Fujirebio, which has expertise in regulatory affairs, and is the result of the H.U. Group working as one with Shizuoka Cancer Center. Preparations for insurance coverage of the System are currently underway. After insurance coverage is granted, SRL will accept requests from medical institutions, and testing will be conducted at the SRL-Shizuoka Cancer Center Joint Inspection Organization.

The H.U. Group and Shizuoka Cancer Center aim to realize personalized medicine optimal for each patient. They will continue to contribute to the popularization and development of cancer genomic medicine by utilizing research and development results obtained through activities such as Project HOPE, as well as SRL's advanced know-how in specimen testing technology and contracted clinical testing.

[Product Overview] General Name: Gene mutation analysis program (for cancer genome profiling tests) Brand Name: Fujinokuni HOPE OncoPanel Manufacturing and Sales Approval Number: 30800BZX00090000 Marketing Authorization Holder: Fujirebio Inc.