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-intensive manual WBC differential procedures, and improves turnaround time for results critical to patient care. Prior to Sysmex's automated immature granulocyte counting, manual differential counting of immature granulocytes was slow, expensive and imprecise.
About Reticulocytes and the Sysmex RET-He Parameter
The RET-He parameter is a sensitive measurement of iron available for red cell production. Functional iron available for incorporation into the red cell hemoglobin can be monitored via the RET-He, thus assisting physicians monitoring disease states where iron deficiency is often seen. Less than normal hemoglobin content in reticulocytes, immature red blood cells (RBCs), is an indication of inadequate iron supply relative to demand. The amount of hemoglobin in these reticulocytes also corresponds to the amount of hemoglobin in mature RBCs. The RET-He parameter provides a direct measurement of the mean reticulocyte hemoglobin content. Therefore, it is a useful parameter for assisting physicians with early diagnosis of iron deficiency (iron restricted erythropoiesis), and for optimizing iron therapy.
About Sysmex America, Inc.
Sysmex America, Inc., the U.S. headquarters of Sysmex Corporation (Kobe, Japan), is a world leader in clinical laboratory systemization and solutions, including clinical diagnostics, automation and information systems. Serving customers for over 40 years, Sysmex focuses on extending the boundaries of diagnostic science while providing the management information tools that make a real difference in clinical and operational results for people worldwide. For more information about Sysmex, please visit http://www.sysmex.com/usa.
CONTACT: Tammy Kutz, Manager, Media & Events of Sysmex America, Inc.,
+1-847-996-4531, kutzt@sysmex.com
Web site: http://www.sysmex.com/usa/
