Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) announces that the Automated Hematology Analyzer XN-31, a new product in the hematology field that has an automatic measurement function for red blood cells infected by malaria parasites, is having a CE mark. The CE mark indicates that the product complies with the European IVD Directive. The Company plans to begin selling this product in Europe, with launches in Africa and Asia as soon as regulatory approvals are received in individual countries.1 Along with hematology parameters generally used for blood testing (CBC8 parameters2), automatic measurement by the XN-31 can determine in approximately one minute whether red blood cells are infected by malaria parasites. Current malaria testing is performed using microscopes or rapid diagnostic tests, and they are not free of challenges.
The XN-31 helps resolve these issues, and will improve standardization and efficiency in malaria testing. The Company will promote efforts to obtain regulatory approval in various countries. Through broad-based introduction of the product in countries where malaria is endemic, and in advanced countries that are working to prevent and manage imported malaria cases, we will contribute to global efforts to eradicate malaria.
The World Health Organization (WHO) has identified malaria as one of the world’s three major infectious diseases. Malaria is a protozoal infection resulting from plasmodia transmitted by mosquitos. In 2017, malaria affected some 220 million people, causing approximately 440,000 reported deaths.3 In 2015, the United Nations (UN) announced its Sustainable Development Goals (SDGs). One of the important themes of the SDGs was halting the spread of malaria, as well as HIV/AIDS, tuberculosis and other diseases. Currently, international organizations are engaging in a host of activities aimed at malaria elimination.
Malaria parasites enter a person’s body due to a bite by a mosquito carrying the plasmodium. After a certain incubation period, circulating red blood cells are infected, and the patient begins to exhibit such symptoms as high fever, headache, vomiting and anemia. Current malaria testing mainly involves viewing infected blood cells under a microscope or using rapid diagnostics tests that employ antigen–antibody reactions. Both methods require around 15–30 minutes, and microscope testing requires skilled technicians.
We have identified the “resolution of medical issues through products and services” as one of the priority issues for realizing a sustainable society and sustainable growth for Sysmex. As one aspect of this approach, we aim to contribute to the early detection and treatment of malaria by supporting improved efficiency and standardization in malaria testing.
The Automated Hematology Analyzer XN-31 is now having a CE mark. Applying the flow cytometry technology we developed in the hematology field, the XN-31 supports standardization and improved efficiency in malaria testing by automatically determining using a 405nm semiconductor laser—within around one minute, to a high level of precision and without requiring manual sample preparation—whether red blood cells are infected by malaria parasites. In clinical evaluations in South Africa and India, the XN-31 determined the presence of red blood cells infected by malaria parasites with a high degree of sensitivity and specificity.4 As a clinical application, therefore, the instrument can be used as a diagnostic aid for malaria.5
The XN-31 presents flagging information6 that can be used to predict whether a patient has Plasmodium falciparum —the species that has the greatest likelihood of becoming severe, with a high rate of death—or other species. In addition to parameters that indicate the presence and quantity of red blood cells infected by malaria parasites and the ratio of red blood cells infected by malaria parasites to the total red cell count (the percentage parasitemia), the XN-31 also automatically determines the CBC8 parameters, including hemoglobin. This enables determination at a glance of a patient’s anemia status—anemia being common among malaria patients.
The WHO has designated today, April 25, as World Malaria Day, and efforts to eradicate malaria are underway around the world. It is possible to reduce the number of people who are infected by this disease through appropriate malaria prevention measures and through early detection and treatment.
Through the broad-based introduction of the XN-31 in countries where malaria is endemic, and in developed countries that are working to prevent and manage imported malaria, we will contribute to early detection and treatment. To this end, in addition to introducing the product into the European market, we will seek regulatory approval in other countries and gradually expand the launch region.
Going forward, Sysmex will continue working to resolve medical issues through business activities and promote efforts that improve access to healthcare. We will also continue to instill trust and confidence among our customers in developing countries and all over the world.
Note: As of the date of this release, the product described herein is for export only and may not be used as a medical instrument in Japan.
Name: Automated Hematology Analyzer XN-31
Target facilities: University hospitals, specialist hospitals, commercial labs, others
Target markets: Europe (also gradual expansion into African and Asian countries)
Launch: To be launched successively in individual countries after receiving regulatory approval
Parameters measured: MI-RBC#/MI-RBC%7, RBC, WBC, PLT, HGB, HCT, MCV, MCH, MCHC
Flagging information6: Information on the malaria species (Plasmodium falciparum or others)
Research parameters: Information related to the life stage of the malaria parasites (such as ring-form, trophozoite, schizont or gametocyte)
Processing capacity: Up to 55 tests/hour (LM mode)
1 As of the date of this release, medical products/instruments having CE Mark are allowed to be sold in European countries. We will begin launching the product in some countries in Africa and Asia once approvals in those countries have been obtained.
2 CBC8 parameters: This refers to red blood cell count, white blood cell count, platelet count, hemoglobin volume, hematocrit value, mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH) and the mean corpuscular hemoglobin concentration (MCHC) of peripheral blood.
3 Source: WHO World Malaria Report 2018
4 Sensitivity: 100% (95% confidence interval 97.0%–100%), specificity: 100% (95% confidence interval 92.6%–100%)
Source: E. Pillay et al. “Evaluation of automated malaria diagnosis using the Sysmex XN-30 analyser in a clinical setting” Malaria Journal 2019 18:15 doi.org/10.1186/s12936-019-2655-8
5 Diagnosis is not possible using these results alone. A confirmed diagnosis is the result of a doctor’s overall judgment, including the use of other clinical information.
6 Flagging information: This information functions as a notification when values are outside the range of standard values set in advance, and indicates the possibility of identified abnormal specimens. It is used only as auxiliary test data and has no direct connection to diagnosis. And this information is for Research purposes only and is not covered by the CE Mark.
7 MI-RBC#/MI-RBC%: The count of red blood cells infected by malaria parasites and the ratio of red blood cells infected by malaria parasites to the red blood cell count.
*Information contained in the press release is current as of the date of the announcement, but may be subject to change without prior notice.