Resolution of Medical Issues through Products and Services

Resolution of Medical Issues through Business Activities

An R&D Structure That Generates a Variety of Technologies

Sysmex develops technology platforms to analyze genes, proteins and cells. Through their multifaceted application, we will create new testing and diagnostic technologies that are useful to patients. At Technopark, our hub for R&D, a variety of researchers and engineers in a host of fields collaborate and engage in R&D on instruments, reagents, and software in response to customer needs. In April 2019, we opened Technopark East Site, a bio-diagnostic reagent base. Bio Port, one of the base’s facilities, develops reagent substances and utilizes reagents’ analytical functions to augment reagent performance and quality, as well as contributing to faster development. We have built a global R&D structure comprising R&D facilities in the United States, Germany, and other countries.

In addition, through open innovation we are pursuing collaboration with research institutes, universities, and medical institutions in Japan and around the world. As part of this effort, we have set up an open innovation lab within Technopark, where we can conduct collaborative R&D with researchers from outside the Company, and we are promoting R&D toward the realization of personalized medicine.

Cancer Genomic Medicine Initiatives

In addition to a confirmed diagnosis, in recent years cancer treatment requires numerous tests using genes and proteins for efficacy prediction, recurrence monitoring, and other aspects of treatment. One such aspect, clinical sequencing tests for cancer, involves the simultaneous measurement of several hundred genes in tumor tissue, comprehensively profiling abnormalities in a patient’s cancer-specific genes. This profiling provides useful information to help in cancer diagnosis and treatment, including the selection of anti-cancer drugs.

Sysmex has developed the OncoGuide™ NCC Oncopanel System, for use in cancer genome profiling, in collaboration with the National Cancer Center. This system was the first in Japan to receive manufacturing and marketing approval following designation under the Ministry of Health, Labour and Welfare’s Sakigake Designation System. The system was launched in January 2019, and RIKEN GENESIS has begun providing an assay service. On June 1, 2019, this became the first cancer genome profiling system in Japan to receive insurance coverage. This is expected to increase opportunities for more patients to receive testing.

Provision of Tests That Reduce the Burden on Patients

Revohem FIX Chromogenic

Hemophilia is caused by a deficiency in a coagulation factor, which causes hemostatic irregularity. Diagnosis and treatment monitoring require quantitative testing of the coagulation factor. In the past, tests using an APTT1 reagent were widely used. However, with this method, measurement values are known to deviate, depending on the type of reagent used. In recent years, demand for tests using chromogenic assay has emerged. With chromogenic assay, drugs to extend the half-life of coagulation factors2 are expected to reduce the burden on patients by decreasing the frequency of intravenous injections, and the chromogenic assay has demonstrated clinical usefulness in post-therapeutic monitoring.

In addition to Revohem FVIII Chromogenic, a blood coagulation factor VIII measurement kit which helps to diagnose and assist in the treatment of hemophilia A, in December 2018 Sysmex launched Revohem FIX Chromogenic to help diagnose and assist in the treatment of hemophilia B. Revohem FIX Chromogenic is the first kit on the market in Japan for measuring coagulation factor IX in blood plasma using chromogenic assay as its measurement principle. With this product, Sysmex aims to enhance the quality of testing and help reduce patient burden.

In addition, using current methods, measuring the function of high-density lipoprotein (HDL), which transports cholesterol clogging the arteries to the liver for recovery, was complicated. Obtaining stable test results quickly was an issue, as obtaining consistent measurement values was problematic and test required several days. Through joint research by the Division of Evidence-Based Laboratory Medicine (Sysmex) and the Kobe University Graduate School of Medicine, Sysmex has created a new measurement method for assessing HDL function. This method uses the Company’s platform, the HI-1000—an Automated High-sensitive Immunoassay System for Research Applications—to automate this new measurement system, allowing HDL function to be assessed in around 30 minutes. In December 2018, we began providing HDL function measurement as a research assay service. Through this service, we aim to aid in the amassing of broad-ranging clinical evidence, including HDL-targeted drug discovery and epidemiological research, and contribute toward the creation of new methods for diagnosing and treating atherosclerosis-related diseases.

  1. Activated partial thromboplastin time (APTT): This testing parameter is used when determining activation and abnormalities among intrinsic coagulation factors. This parameter is used along with prothrombin time (PT) to determine activation and abnormalities among extrinsic coagulation factors when screening for hemostatic function.
  2. These drugs extend the half-life of blood plasma beyond that of conventional blood coagulation factor drugs, allowing for regular administration only once every three to five days—or once per week depending on the patient’s disease state. Such drugs are therefore expected to decrease the frequency of intravenous injection, reducing the burden on the patient.

Improvements to Healthcare Environments Using IT

In March 2018, Sysmex launched Caresphere™, a new network solution.

Caresphere™ utilizes the Internet of Things (IoT) and the Cloud to link and analyze a variety of information in real time, such as that from testing instruments and laboratory information systems. In addition, Caresphere™ provides a standardized global platform that is seamless and safe. This platform facilitates centralized information management to reinforce operational efficiency and quality control in hospitals and commercial laboratories. This solution flexibly extracts information and makes it visible to help increase operating efficiency, raise quality, and enhance patient satisfaction.

In the future, we intend to expand the platform, developing applications and services for regional healthcare facilities and the broad range of healthcare professionals involved with them. We aim to offer solutions that help improve productivity and quality in clinical testing and healthcare as a whole.