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Three Independent Studies Include the ImmuKnow(R) Assay to Manage and Optimize Immunosuppression Therapy in Transplant Patients
Date:5/31/2009

was preceded by a deviation in baseline ImmuKnow status. Immunosuppression was adjusted in each case, accordingly, without evidence of graft loss or clinical symptoms." He concluded by saying, "Viral surveillance together with ImmuKnow can be useful to prevent infection or organ rejection by tailoring immunosuppressive therapy." For each patient, viral studies and ImmuKnow results were routinely obtained and immunosuppressive drug dosing was adjusted based on positive viral studies using ImmuKnow results as an adjunct tool.

In a related study, researchers at the University of North Carolina at Chapel Hill and Ohio State University prospectively studied the use of the ImmuKnow assay together with various viral markers in 93 renal transplant recipients. Lead study investigator, Dr. Kenneth A. Andreoni, summarized the results of the study by saying, "We collected ImmuKnow data along with viral monitoring. From our data, we feel we may be able to prevent some viral infections by decreasing immunosuppression when ImmuKnow assay values are <100ng/ml or when post-transplant baseline ImmuKnow values decrease by >50%." Among patients who developed elevated viral levels, the majority either displayed an ImmuKnow value <100ng/ml or >50% decrease in baseline ATP value. In several of these patients, low ImmuKnow results led directly to immunosuppression medication decreases and subsequent increases in ImmuKnow with no infections or rejections.

The use of the ImmuKnow assay as described in these studies has not been cleared by the U.S. Food & Drug Administration.

About ImmuKnow

ImmuKnow is a noninvasive biomarker of immune function that assesses cellular immune status by detecting cell-mediated immunity (CMI) in adult immunosuppressed patients. It measures the concentration of adenosine triphosphate (ATP) released from CD4 cells following cell stimulation. T
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SOURCE Cylex, Inc.
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