Sysmex America Set to Launch New XT-Series(TM) ...( FDA-Cleared Parameters Aid in the Di...)

FDA-Cleared Parameters Aid in the Diagnosis of Infectious and Inflammatory

Diseases and in Monitoring Iron Deficiency

MUNDELEIN, Ill., Oct. 30 /PRNewswire/ -- Sysmex America, Inc. today announced that the United States Food and Drug Administration (FDA) has cleared Sysmex's Immature Granulocyte (IG) parameter and Reticulocyte Hemoglobin Equivalent (RET-He) parameter for use on the company's XT-Series(TM) Automated Hematology Analyzers for low to mid-volume laboratories, said John Kershaw, President, Sysmex America, Inc. This announcement follows the company's earlier clearances of the same parameters for the Sysmex XE-Series(TM) Automated Hematology Analyzers. Now, clinical laboratories of any size can potentially benefit from enhanced diagnostic information, workflow process improvement, and greater cost-effectiveness, added Kershaw. The IG parameter is now available on both the XT-2000i and the XT-1800i, and the RET-He is available on the XT-2000i Automated Hematology Analyzers. Sysmex is the only company able to provide both of these FDA-cleared parameters.

"As a partner to clinical laboratories nationwide, Sysmex is committed to expanding the clinical utility of our hematology product line. These FDA clearances demonstrate our company's dedication to best-in-class hematology products and empowers clinical laboratories to improve their operations while enhancing patient care," said Kershaw.

About Immature Granulocytes and the Sysmex IG Parameter

The identification of immature granulocytes is primarily of importance in the diagnosis of infectious and inflammatory diseases. The IG parameter on the Sysmex XT-Series Automated Hematology Analyzers provides a quantitative immature granulocyte count for metamyelocytes, myelocytes and promyelocytes by utilizing Sysmex's patented fluorescent flow cytometry technology. This patented technology, used to separate white blood cells into distinct cell clusters, reduces labor-i
'/>"/>