Expansion of the Genetic Testing Business Using Proprietary Technology

「September 2025: 株式会社理研ジェネシス, our subsidiary, obtained manufacturing and marketing approval for the OncoGuide OncoScreen Plus CDx System. The product can be used as a companion diagnostic for unresectable or recurrent breast cancer that is hormone receptor (HR)-positive and HER2-negative, with PIK3CA, AKT1, or PTEN gene mutations, for which combined therapy with the Tulcarp® 160 mg/200 mg tablets and Faslodex® is indicated. In September 2025, our subsidiary Oxford Gene Technology obtained U.S. Food and Drug Administration (FDA) marketing authorization under the De Novo pathway for the CytoCell KMT2A Breakapart FISH Probe Kit PDx.」

「June 2024: 株式会社理研ジェネシス, our subsidiary, obtained domestic manufacturing and marketing approval for the in vitro diagnostic product OncoGuide™ EpiLight™ Methylation Detection Kit, jointly developed with Tohoku University Hospital, for use in assisting the selection of treatments for colorectal cancer.」

「August 2023: The PrismGuide™ IRD Panel System, which provides information useful for identifying the causative genes of IRD by obtaining a comprehensive genomic profile from the blood of patients with or suspected of having inherited retinal dystrophy (IRD), and which received domestic manufacturing and marketing approval in May 2023, became the first IRD genetic panel testing system in Japan to receive reimbursement coverage.」

「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 the personalized medicine field, which is expected to achieve substantial growth, we will develop new items using our strengths in liquid biopsy technologies involving genes, cells, and proteins. By leveraging our existing research-use products and technologies, we aim to commercialize and bring to market technologies that will lead the personalized medicine field.」

「February 2021: We obtained approval for a partial change to the manufacturing and marketing approval for the genetic mutation analysis set for cancer genomic profiling testing, OncoGuide™ NCC Oncopanel System, which we manufacture and market. The system can now detect mutations and amplifications in 124 genes, fusions in 13 genes, and microsatellite instability (MSI), enabling the provision of more detailed genetic information to assist physicians in determining treatment policies, including diagnosis and anticancer drug selection.」

「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 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.」

「We acquired all shares of Oxford Gene Technology IP Limited (OGT). As a result, OGT and its subsidiaries became our subsidiaries from the first quarter of the current consolidated fiscal year. The purpose of the acquisition is to strengthen the foundation of our life science business by acquiring OGT's business and expertise in cytogenetic testing and its capabilities in developing reagents for next-generation sequencers.」

「We acquired shares in Oxford Gene Technology IP Limited (OGT) and made it a subsidiary. In the cytogenetic testing market, we will strengthen our technological foundation in genomic medicine by combining our automation technologies, such as flow FISH, with OGT's high-quality reagent development capabilities.」

「Under these circumstances, we acquired shares in Oxford Gene Technology IP Limited (OGT) and made it a subsidiary. In the cytogenetic testing market, we will strengthen our technological foundation in genomic medicine by combining our automation technologies, such as flow FISH, with OGT's high-quality reagent development capabilities.」

「We acquired all shares of Oxford Gene Technology IP Limited (OGT). As a result, OGT and its subsidiaries will become our subsidiaries from the following consolidated fiscal year. The purpose of the acquisition is to strengthen the foundation of our life science business by acquiring OGT's business and expertise in cytogenetic testing and its capabilities in developing reagents for next-generation sequencers.」

「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.」

「The allocation of the acquisition cost was completed as of the end of the second quarter of the current fiscal year.」

「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.」

「Expanding the genetic testing business by leveraging proprietary technology」