Approval of Manufacturing and Marketing for Cancer Gene Testing System 'Fujinokuni HOPE OncoPanel'

We are pleased to announce that the gene mutation analysis program (for cancer genomic profiling) 'Fujinokuni HOPE OncoPanel' (hereinafter 'the System'), jointly developed by SRL, Inc. (Headquarters: Minato-ku, Tokyo; President: Makoto Matsumoto; hereinafter 'SRL'), Shizuoka Cancer Center (Location: Nagaizumi-cho, Shizuoka; President: Katsuhiko Uesaka; hereinafter 'Shizuoka Cancer Center'), SRL-Shizuoka Cancer Center Joint Laboratory Co., Ltd., and Fujirebio Inc. (Headquarters: Minato-ku, Tokyo; President: Ken Fujita; hereinafter 'Fujirebio'), received manufacturing and marketing approval from the Ministry of Health, Labour and Welfare on March 24, 2026. This is the first medical device program for which the H.U. Group has obtained manufacturing and marketing approval.

The System is a result of 'Project HOPE' (High-tech Omics-based Patient Evaluation), a joint research initiative between Shizuoka Cancer Center and SRL. It is the only system in Japan developed based on data from 5,143 Japanese cancer patients. By performing matched-pair analysis comparing tumor tissue and blood from the same patient, the System analyzes changes in 410 cancer-related genes and drug-metabolizing enzyme-related genes. Obtaining this information collectively assists in cancer diagnosis and treatment planning.

The approval was obtained with the cooperation of Fujirebio, which possesses expertise in pharmaceutical affairs, representing a collaborative effort across the H.U. Group and Shizuoka Cancer Center. We are currently preparing for the System to be covered by national health insurance. Once covered, SRL will accept requests from medical institutions, and the testing will be conducted at the SRL-Shizuoka Cancer Center Joint Laboratory.

Aiming to realize personalized medicine tailored to each patient, the H.U. Group and Shizuoka Cancer Center will continue to contribute to the spread and development of cancer genomic medicine by leveraging research outcomes from Project HOPE and SRL's advanced expertise in clinical testing.