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FDA Approves Beckman Coulter Anemia Test & Diagnostic Index - Aids Chronically Ill
Access® sTfR Assay Helps in Treatment of Chronically Ill Patients with Anemia.
ORANGE COUNTY, Calif. (December 18, 2008) – Beckman Coulter announces U.S. Food and Drug Administration approval for the Access® Soluble Transferrin Receptor (sTfR) Assay and the sTfR/log ferritin index (sTfR Index) as an aid in the diagnosis of iron deficiency anemia (IDA) and the differential diagnosis of IDA and anemia of chronic disease (ACD). The automated sTfR assay used in combination with the sTfR Index, which is calculated on-board Beckman Coulter’s Access and UniCel® DxI® instruments, produces a recommended cutoff that can indicate the nature of a patient’s anemia. The cutoff can assist a physician in determining the best course of treatment, especially for the chronically ill.
Together, the Access sTfR assay and sTfR Index are new and important diagnostic tools for physicians that aid in diagnosis, and simplify the complex etiology of anemia.
According to Dr. Robert Means, MD., University of Kentucky College of Medicine , “While it is fairly easy to diagnose the cause of anemia in an otherwise healthy population where iron deficiency is generally the most common cause – such as in a prenatal care clinic, the difficulty comes with that large segment of the population with significant concurrent illnesses, where ferritin, transferrin and iron are all altered as part of the inflammatory response, and where the anemia of chronic disease (ACD) is a major contributor. The sTfR index will allow the separation of ACD from both simple iron deficiency and iron deficiency in patients with concurrent inflammation.”
sTfR is intended, along with other indicators of iron status, as an aid in the diagnosis of iron deficiency anemia, especially in patients with chronic disease. Beckman Coulter, Inc. offers an array of diagnostic tools in chemistry, hematology and data management that, when used in conjunction with the Access sTfR assay, provide a comprehensive diagnostic solution for anemia disease management.
“With Access sTfR, labs can confidently provide physicians with information that can reduce the cost of care associated with anemia, while benefiting the patient’s outcome.” said John Blackwood, vice president and general manager of the Immunoassay Business Center at Beckman Coulter, Inc.
A clinical trial was conducted to show the effectiveness of Access sTfR and the sTfR/log ferritin index in differentiation of in this group of difficult to diagnose patients. A total of 145 patients were enrolled: 57 with ACD; 27 with IDA; 61 with ACD + IDA. The study demonstrated that subjects with IDA or ACD + IDA had significantly higher sTfR/log ferritin index values than subjects with ACD (p<0.0001)².
Beckman Coulter, Inc., based in Orange County, California, develops, manufactures and markets products that simplify, automate and innovate complex biomedical tests. More than 200,000 Beckman Coulter systems operate in laboratories around the world, supplying critical information for improving patient health and reducing the cost of care. Recurring revenue, consisting of supplies, test kits, service and operating-type lease payments, represents approximately 78 percent of the company’s 2007 annual revenue of $2.76 billion. For more information, visit www.beckmancoulter.com.
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