Hitachi High-Tech Corporation ("Hitachi High-Tech") and Gencurix, Inc. ("Gencurix") have entered a strategic partnership (the Partnership) in the field of cancer molecular diagnostics(1). The Partnership aims to develop a testing service for the cancer molecular diagnostics by combining Hitachi High-Tech's core expertise in R&D and manufacturing of in vitro diagnostic products and digital technology, and Gencurix's technology and experience in biomarker(2) discovery for cancer diagnosis and development of molecular testing service. As a part of the Partnership, both companies concluded a Feasibility Study (FS) agreement to examine the feasibility of the business and completed the checkpoints defined in this FS agreement in June 2024. As the next step, Hitachi High-Tech and Gencurix are planning commercialization of testing services in Japan.

In recent years, cancer treatments have begun to offer "personalized medicine," in which genes and proteins are examined in detail for precise diagnosis and treatment selection, and the treatment is tailored to the individual patient. As treatment modalities evolve, doctors and patients are facing with increasing opportunities to choose treatment, and clinical testing is becoming more important in supporting that choice. In the field of cancer diagnosis, where new drugs and treatments are rapidly being developed, there is a need to discover appropriate biomarkers, establish testing methods, and use digital technology to provide reports promptly with high medical value.Under these circumstances, Hitachi High-Tech, strengthening its molecular diagnostics business, and Gencurix, being specialized in biomarker discovery technology, will join forces to develop highly reliable testing services for cancer diagnosis.

In April 2024, Hitachi, Ltd.("Hitachi") and Hitachi High-Tech consolidated Hitachi's Healthcare Business Division (radiation therapy, digital healthcare, etc.) to Hitachi High-Tech to promote the healthcare business based on "Diagnosis x Therapy x Digital" and create healthcare innovation. Especially in area of in vitro diagnostics area, we have contributed to improve quality and efficiency of testing with a product lineup that includes in vitro diagnostic equipment that analyzes blood and other specimens to support the diagnosis of diseases, and DNA sequencers. This Partnership is part of Hitachi High Tech's growth strategy of strengthening this molecular diagnostics business. Towards creating "a society without fear of cancer," Hitachi High-Tech aims to contribute to the improvement of people's QoL (Quality of Life) through "personalized medicine" and "sophisticated diagnosis of intractable diseases."

Gencurix is a leading life science company established in 2011 in Seoul, Korea, engaged in the discovery of biomarkers for cancer diagnosis, the provision of testing services, and the sale of testing kits. Gencurix provides molecular diagnostic solutions across the cancer care process, from early detection to prognosis, companion diagnostics(3) and recurrence monitoring. Gencurix operates in Korea, Europe, and other countries around the world, and promotes joint development with pharmaceutical companies.

Hitachi High-Tech and Gencurix will jointly develop cancer diagnostic tests required in clinical practice to promote personalized medicine in the oncology field and aim to provide highly reliable testing service solutions using digital technology. We will first jointly launch a testing service business in Japan and then in other countries.

(1) Molecular diagnostics: Molecular diagnostic involves measuring biomolecules such as DNA, RNA, and protein contained in tissues and blood (body fluids) and provides information necessary for diagnosis or selection of therapeutic drugs to healthcare professionals.
(2) Biomarker: A biomarker is a test item or biological substance that is an indicator of the presence or absence of a certain disease, a change in a disease status, or a therapeutic efficacy. Biomarkers are becoming increasingly important and enabling personalized medicine in specific disease areas such as cancer. In addition to being used as indicators to measure therapeutic efficacy, biomarkers are also expected to be used as indicators for disease prevention in the future.
(3) Companion diagnostics: In vitro diagnostics to test the indication of a specific drug to improve the efficacy or safety of the drug.

About Gencurix

Gencurix is a molecular diagnostics company for cancer that provides digital PCR-based products and testing services based on a liquid biopsy, biomarker discovery and commercialization platform. Under the motto "Best in Class," Gencurix strives to solve clinical unmet needs with new technologies and testing products.Key products include GenesWell BCT, a breast cancer prognostic test, and Droplex's line of companion diagnostics for a wide range of cancers, including lung, colorectal and endometrial cancers. Gencurix has developed early diagnostic tests for major cancers, including liver and colorectal cancer, and is promoting clinical research. As written, Gencurix provides molecular diagnostic solutions across the cancer care process, from early detection to prognosis, companion diagnostics and recurrence monitoring.For further information, visit https://www.gencurix.com/

About Hitachi High-Tech

Hitachi High-Tech, headquartered in Tokyo, Japan, is engaged in activities in a broad range of fields, including manufacture and sales of clinical analyzers, biotechnology products, radiation therapy systems, semiconductor manufacturing equipment, analytical instruments, and analysis equipment. Also, we provide high value-added solutions in industrial fields such as mobility, connected, environment and energy, etc. Through business based on our core Observation, Measurement and Analysis technologies, we will contribute to the realization of a sustainable society by solving social issues.The company's consolidated revenues for FY2023 were approx. JPY 670.4 billion. For further information, visit https://www.hitachi-hightech.com/global/en/

Contact:
Business Development Dept., Diagnostic System Business Strategy Planning Div.,Diagnostic System Business, Healthcare Business Group,Hitachi High-Tech Corporation
www.hitachi-hightech.com/global/en/contactus/#sec-2

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