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Liquid biopsy is used in the measurement and diagnosis of disease-derived substances (such as genes, proteins and cells) in blood, urine and other bodily fluids. As it requires the measurement of minute quantities of substances that have leaked from the disease focus into the blood and other bodily fluids, liquid biopsy requires substantially higher levels of sensitivity than the conventional approach of physical biopsy, which involves resecting a portion of tumor and other tissue.

The immunoassay, a technology for measuring proteins, is already used widely for immunochemistry testing in clinical laboratories, from diagnosing infectious disease, cancer and cardiovascular disease to monitoring their courses of treatment. In 2007, Sysmex launched the fully automated immunoassay system HISCL-2000i that uses chemiluminescence enzyme immunoassay (CLEIA) as a measurement principle. Through such efforts, we have been working to expand our lineup of systems and reagents to achieve higher levels of sensitivity and speed in immunochemistry testing.

The HI-1000 is a highly sensitive, fully automated immunoassay system for research use, which combines CLEIA with the immune complex transfer method¹, achieving a high level of sensitivity by reducing background noise stemming from non-specific binding². This method achieves sensitivity levels ranging from several tens to several thousands of times higher than conventional methods³, allowing proteins to be detected at levels of less than one pg⁴/mL. This sensitivity promotes R&D into the measurement of blood biomarkers in minute quantities that were difficult to measure in the past. Furthermore, customers can set the system to an environment appropriate to their target biomarkers, setting reaction time, temperature and multiple other parameters as they wish.

To encourage the development of new biomarkers called for by customers, we plan to develop reagents and set up various parameters necessary for measurement with the HI-1000, develop and produce reagent substances employing our recombinant protein production technologies, which are needed for developing reagents, perform outsource measurement using these developed reagents for accumulation of evidence, and offer various other services.

Going forward, Sysmex will continue working with customers to promote R&D into utilization of high-value biomarkers for realizing personalized medicine, thereby contributing to the development of healthcare.