"This independent clinical research study from three world renowned transplant centers provides important new evidence regarding the potential clinical utility of the measurement of cell mediated immunity using the ImmuKnow test," said Paul R. Sohmer, MD, acting Chief Executive Officer of Cylex. "We hope that studies such as this will contribute to the growing body of literature regarding the importance of measuring cell mediated immunity in transplantation."
The use of the ImmuKnow assay for identification of patients at risk for kidney rejection, as described in this study, has not been cleared by FDA. The company may use data from this study or similar studies to support a future FDA marketing application for a similar indication.
Cylex's ImmuKnow immune cell function assay detects cell-mediated immunity (CMI) by measuring the concentration of ATP from CD4+ cells following stimulation. The assay is used for the detection of cell-mediated immunity in an immunosuppressed population. The ImmuKnow test is a qualitative assay and does not directly quantify the level of immunosuppression. Results of ImmuKnow should be used in conjunction with clinical presentation, medical history, and other clinical indicators when establishing the immune status of a patient.
About Cylex, Inc.
Cylex is a global life science company that develops and manufactures
research and in vitro diagnostic products that are intended to illuminate
immunity. ImmuKnow(R) is an in vitro diagnostic utilized to detect cell
mediated immunity in an immunosuppressed population, and is increasingly
being adopted at organ transplant centers throughout the country. The
Company's patented technology provides an innovative platform allowing
clinical researchers to simply and reproducibly measure
|SOURCE Cylex, Inc.|
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