NEW YORK ─ Sysmex said on Thursday that it has received marketing approval in Japan for its Automated Hematology Analyzer XN-31, making it available for the in vitro diagnosis of malaria in the country.
The automated hematology analyzer helps diagnose malaria by conducting qualitative analyses of formed elements in whole blood. The analyses are based on counting DNA-containing, malaria-infected red-blood cells that have malaria parasites, the firm said. Measurements are done by means of electric impedance, light scattering by irradiating laser light onto cells that move inside a flow cell, or dye binding, Sysmex added.
The automated analyzer also counts, quantitates, and identifies platelets, red blood cells, and white blood cells; measures hemoglobin; and determines hematocrit values, corpuscular constant, red blood cell distribution width, platelet distribution width, mean platelet volume, plateletcrit, and large platelet fraction.
The product will be used to test people with suspected malaria who travel to Japan. Citing the World Health Organization, Sysmex said that each year about 30,000 people globally, traveling for vacation or business, get infected with malaria at their destinations and are diagnosed after they return home, and Japan is no exception.
The Kobe, Japan-based diagnostics company said it will look to obtain regulatory approval in additional countries to accelerate the analyzer's market introduction in Asia and Africa.
Marketing approval as a medical device with high-level control is required as part of the procurement criteria for funding from international and other organizations, Sysmex noted. The firm added that through partnerships with such funding organizations, it aims to launch the automated analyzer in countries and regions, either emerging or developing, where medical resources are limited.
Sysmex obtained CE-IVD marking for the analyzer in April 2019, making it available to countries in the European Union and others that accept the designation. The firm anticipates launching the product in Japan in August.