Sysmex Europe

Sysmex Obtains First Marketing Approval in Japan for the Automated Hematology Analyzer XN-31 as a Class III Specially Controlled Medical Device to Diagnose Malaria

For Use as a Measure against Imported Infectious Diseases in Japan and Accelerating its Introduction to the Asian and African Markets

Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) announced today that it has obtained a medical device marketing authorization ("marketingapproval") for its Automated Hematology Analyzer XN-31 as a Specially Controlled Medical Device foruse inthe diagnosis of malaria(Class III)1 for the first time in Japan.

With this, it is now possible to use this analyzer for clinical useas a measure against imported infectious diseases in Japan.Now that marketingapproval has been received in Japan, we will accelerate our move to obtain marketingapproval in other countries in Asia and countries in Africa, thus contributing to global efforts to eliminate malaria.

Identified as one of the world's three major infectious diseases by the World Health Organization (WHO), malaria is a protozoal disease resulting from plasmodia transmitted by mosquitoes, and is prevalent in tropical and sub-tropical regions around the world. When malarialparasites enter a person's body, circulating red blood cells (RBCs) are infected after a certain incubation period, and the  patient  begins  to  exhibit  symptoms such as  high  fever,  headache,  vomiting,  and  anemia. According to the World Malaria Report 2019 by the WHO, approximately 4.0 billion persons, or about half of the world population, are at risk of malaria; approximately 230 million persons were infectedby it in 2018, and an estimated 410,000 persons died from it in the same year. The report also statedthat every year at least30,000 persons, either on vacation or business, get infected by malaria at their destinations, including non-epidemic areas, and diagnosedthe disease after they return home. Japan is no exception to this, and more than 50 such cases are reported annually, although malaria has been formallyeradicated in thiscountry. Because delay in diagnosis and treatment can lead to a worsening of symptoms, early diagnosis2 and efficient and standardized3 testing of malaria are of great importance.

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 of malaria testing throughout the world.

On June 26, 2020, Sysmex obtained marketing approval in Japan for the Automated Hematology Analyzer XN-31, for which a CE certification indicating that the product complies with the European IVD Directive had been obtained in April 2019, making this product the first medical device for in vitro diagnosis approved in Japan as a Specially Controlled Medical Deviceforuse inthe diagnosis of malaria(Class III). Early diagnosis and treatment of malaria can reduce the number of deaths amongthose who contract it. Through this product, which is capable of providing quick and easy testing results useful in diagnosis inclinical settings, Sysmex wishes tocontribute to measures against imported infectious diseases in Japan. Now that we have received marketingapproval, we are planning to have this technology approved by regulatory authorities in selected countries in Asia and Africa to accelerate its market introduction there.

Domestic marketing approval  as  a medical devicewith high-level  controlis  required  in  the procurement criteria4of international funds and funding from other organizations which work to improve access to healthcare in emerging and developing countries. Through partnerships with such organizations,  we  aim  to  introduce  the  product  to  countries  and  regions,  either  emerging  or developing, where medical resources are limited.

Going forward, Sysmex will continue working to resolve medical issues through business activities and  promote  efforts  that  improve  access  to  healthcare.  We  will  continue  to  inspire  trust  and confidence among our customers in developing countries and all over the world.

Product Overview

Generic name: Malaria diagnostic device (71081003),Automated hematology analyzer (35476000)

Name: Automated Hematology Analyzer XN-31(Medical Device Marketing Authorization Number: 30200BZX00211000)

Classification:Class III

Intended use: This automated hematology analyzer aids the diagnosis of malaria by making qualitative analyses of formed elements in whole blood based on the count of DNA-containing malaria-infected RBCs (MI-RBCs) that contain such as malaria parasites, by way of electric impedance, light scattering by irradiating laser light onto cells that move inside the flow cell, or dye binding.It also counts, quantitates, and identifies platelets, RBCs, and white blood cells, measures hemoglobin, and determines hematocrit values, corpuscular constant, RBC distribution width (RDW), platelet  distribution  width  (PDW),  mean  platelet  volume  (MPV), plateletcrit (PCT), and large platelet fraction.

Launch: The end of August2020

Manufacture and sale: Sysmex Corporation


April  25,  2019press  release  entitled “Sysmex  Obtains  CE  Certification  for  Automated Hematology Analyzer XN-31, Which Has an Automatic Measurement Function for Red Blood Cells Infected by Malaria Parasites -Contributing to the Early Detection and Treatment of Malaria through Standardized and More Efficient Malaria Testing-”



1 Specially Controlled Medical Device(Class III):
A medical device whose failure is deemed to pose a relatively high risk to health.

2 Importance of early diagnosis of malaria:
Partly because malaria had been eradicated in Japan, there are cases where malaria is not suspected and is misdiagnosed as a different disease,or a delay in diagnosis or treatment occurs as malaria testing is not done promptly. Early diagnosis is particularly crucial for tropical malaria because it can become severe if not treated within 24 hours of onset.

3 Importance of increasing the efficiency of,and standardization of,malaria testing:
Current malaria testing uses a microscope or rapid diagnostic test kits. Both methods require around 15-30 minutes, including manual sample preparation, making it difficult to conduct a large number of tests at once. In addition, because microscope testing is largely dependent on the skills of technicians, standardizing malaria testing by, for example, training technicians and systematically assuring the quality of testing and securing a stable source of skilled technicians,arean ongoing issue.4Procurement criteria of international funds and other organizations:The WHO and international funds permit a simplified examination process for high-risk products ifthose products have obtained approval from a rigorous examination body that those organizationsdesignate, with a view toward accelerating the introduction of various products to emerging countries and developing countries. This is stated in their procurement criteria, and regulatory approval as a Specially Controlled Medical Device(Class III) in Japan qualifies as one of theserigorous examination criteria.



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