Diagnostic technology enabling early disease detection and personalized treatment

「In June 2025, we obtained marketing approval for the PrismGuideTMAPOE Genotyping Kit, which determines APOE genotype from genomic DNA in blood and for which we had submitted an application in September 2024. This test reagent, the first of its kind to receive approval in Japan, is expected to predict the risk of adverse effects from anti-amyloid beta antibody drugs used to treat Alzheimer's disease and contribute to shared decision-making (SDM) among attending physicians, patients, and their families. In September 2025, our subsidiary Riken Genesis Co., Ltd. obtained marketing approval for the OncoGuide OncoScreen Plus CDx System. In September 2025, our subsidiary Oxford Gene Technology obtained US Food and Drug Administration (FDA) marketing authorization under the De Novo classification pathway for the CytoCell KMT2A Breakapart FISH Probe Kit PDx.」

「In June 2024, our subsidiary Riken Genesis Co., Ltd. obtained Japanese marketing approval for OncoGuide™ EpiLight™ Methylation Detection Kit, an in vitro diagnostic for use in supporting treatment selection for colorectal cancer, based on joint results with Tohoku University Hospital. In September 2024, we submitted an application in Japan for marketing approval of a reagent that determines APOE genotype from genomic DNA in blood to predict the risk of adverse effects from anti-amyloid beta antibody drugs.」

「In addition, the OncoGuide™ NCC OncoPanel System received reimbursement coverage in Japan as a companion diagnostic for futibatinib, a molecular-targeted drug developed by Taiho Pharmaceutical Co., Ltd., in patients with biliary tract cancer. Accordingly, our subsidiary Riken Genesis Co., Ltd. launched an assay service covered by the national health insurance system under quality assurance compliant with international standards.」

「May 2023: We obtained Japan's first manufacturing and marketing approval for the PrismGuide™ IRD Panel System, which obtains information on disease-causative genes for inherited retinal dystrophy (IRD).」

「In February 2023, we obtained approval for a partial amendment to the marketing approval particulars for the OncoGuide™ NCC OncoPanel System, enabling its use as a companion diagnostic for futibatinib, the generic name of a molecular-targeted drug being developed by Taiho Pharmaceutical Co., Ltd., in patients with biliary tract cancer.」

「⑥ In September 2022, we submitted an application for partial amendment to the marketing approval particulars for the OncoGuide™ NCC OncoPanel System gene mutation analysis set, as a companion diagnostic for patients with advanced biliary tract cancer harboring gene rearrangements, including FGFR2 fusions.」

「In December 2021, we submitted an application for marketing approval of a testing reagent that measures amyloid beta in blood using the HISCL-5000/HISCL-800 Fully Automated Immunoassay Systems and assists in assessing amyloid beta accumulation in the brain.」

「July 2020: We launched OncoGuide™ NET, an expert panel support system designed to improve operational efficiency in expert panels for cancer genomic profiling testing.」

「April 2020: The OncoGuide™ NCC Oncopanel System, a genetic mutation analysis set for cancer genomic profiling testing that became the first in Japan to receive reimbursement coverage in June 2019, was approved as advanced medical care for a prospective study evaluating the feasibility and usefulness for treatment selection of comprehensive genomic profiling testing at initial treatment in patients with solid tumors.」

「The Gene Mutation Analysis Set for Cancer Genomic Profiling Testing, OncoGuide™ NCC OncoPanel System, became the first system in Japan to receive reimbursement coverage for cancer genomic profiling testing.」

「The genetic testing kit for blood cancers, ipsogen JAK2 DX Reagent, for which manufacturing and marketing approval was obtained in December 2018, became eligible for reimbursement coverage in January 2020, and sales began.」

「August 2019: We obtained domestic manufacturing and marketing approval for the RAS gene mutation detection kit OncoBEAM™ RAS CRC Kit. It is Japan's first in vitro diagnostic product for RAS gene mutation testing in colorectal cancer using liquid biopsy.」

「Under these circumstances, the OncoGuide™ NCC Oncopanel System, which had been sold since January 2019 to facilitate the early introduction of cancer clinical sequencing testing in clinical practice, became the first such system in Japan to receive reimbursement coverage in June 2019. 株式会社理研ジェネシス, a subsidiary, established a testing structure to ensure the quality of this test in anticipation of increased demand following reimbursement coverage. By establishing a fully domestic testing workflow including detailed support, the company will contribute to the clinical implementation of cancer genomic medicine in Japan.」

「To facilitate the early introduction of cancer clinical sequencing testing, we obtained Japan's first manufacturing and marketing approval in December 2018 for the OncoGuide™ NCC Oncopanel System, which we had jointly developed with the National Cancer Center Japan, as a system for cancer genomic profiling testing. Testing using this system is currently being conducted at 50 core and affiliated hospitals for cancer genomic medicine, including the National Cancer Center Hospital. We plan to apply for reimbursement coverage for the system to expand patients' access to testing.」

「August 2018: We jointly developed with 凸版印刷株式会社 and 株式会社理研ジェネシス the research-use genetic analyzer LW-100 and related reagents, which fully automate testing for genetic mutations in cancer tissue. The 3 companies began providing the system for research use and are actively verifying its clinical utility with a view to early clinical commercialization, aiming to standardize genetic testing using cancer tissue specimens.」

「April 2018: The multiplex genetic panel testing for personalized medicine conducted using the cancer-related genetic panel testing system jointly developed by us and the National Cancer Center Japan was approved as advanced medical care, and testing began at the National Cancer Center Japan.」

「In April 2017, our group launched a medium-term management plan covering the fiscal years ending March 2018 through March 2020. In addition to strengthening global growth and profitability in our core businesses of hematology, blood coagulation, immunoassay, and urinalysis, we positioned genetic testing and other fields as the next core businesses and pursued their commercialization through active investment.」

「In the cytogenetics testing market, we will strengthen the technology base for genomic medicine by combining our automation technologies, such as flow FISH, with OGT's high-quality reagent development capabilities.」

「In research and development, our target areas are blood and immune diseases, cancer, chronic diseases, and infectious diseases. Using technology platforms including flow cytometry for detecting cells; direct gene amplification and DNA chip technologies for amplifying and detecting genes; chemiluminescence enzyme immunoassay and chromatography technologies for antibody testing; and systems biotechnology for simulating disease states based on measurement results, we aim to create high-value diagnostic technologies that enable early disease detection and the selection of optimal treatment for each patient.」

「The purpose of this acquisition is to strengthen synergies between the consolidated group and Riken Genesis and accelerate efforts to achieve personalized medicine.」

「The purpose of this acquisition is to strengthen synergies between the consolidated group and Riken Genesis and accelerate efforts to achieve personalized medicine.」

「We acquired an equity interest in 株式会社理研ジェネシス (head office: Tokyo) in 2014 and have pursued initiatives to realize personalized medicine. To further strengthen synergies with the company, we acquired additional shares and made it a subsidiary. We and 株式会社理研ジェネシス will pursue research and development and business expansion aimed at realizing personalized medicine through genetic analysis testing.」

「We aim to create high-value diagnostic technologies that enable early disease detection and the selection of optimal treatment for each patient.」