Sysmex obtains for the OncoBEAM RAS CRC kit approval

Sysmex Corporation has obtained Japanese manufacturing and marketing approval for the OncoBEAM RAS CRC kit, used for blood-based circulating tumor DNA molecular testing of mutations in the RAS gene for colorectal cancer patients. This product is the first in vitro diagnostic reagent in Japan to be used for RAS gene-mutation testing for colorectal cancer, using liquid biopsy. Minimally invasive and simpler than conventional physical biopsies of tumor tissue, the new testing method provides detection results on a par with the use of tumor tissue. As a result, this testing method reduces the physical and mental burden on patients, expands testing opportunities, and contributes to the early stage determination of treatment methods. In recent years, demand has grown for the use of liquid biopsy in the diagnosis and selection of treatment methods for cancer and other diseases. Liquid biopsy refers to using blood or other bodily fluids, which place little burden on the patient, rather than physical biopsies, which require taking samples of a cancer tumor or other tissue. The company has defined the resolution of medical issues through products and services as one of the priority issues (materiality) for realizing a sustainable society and sustainable growth in corporate value for Sysmex through the creation of new technologies and markets. As one aspect of these activities, Sysmex is pursuing R&D toward the realization of personalized medicine, which involves the provision of healthcare optimized for individual patients, and the proliferation of testing to reduce the physical burden on patients.

Going forward, the company plans to launch the OncoBEAM RAS CRC Assay Service, an assay service for colorectal cancer using liquid biopsy to detect RAS gene mutations in the blood, at the Sysmex IMP laboratory, located in the Kobe Biomedical Innovation Cluster. To increase the opportunities for more patients to receive the testing, the company plans to apply for Japan’s national insurance coverage for this product.