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An Independent Study Reports on the Utility of ImmuKnow(R), the Cylex(TM) Immune Cell Function Assay, for Monitoring Heart Transplant Recipients
Date:4/24/2009

U.S. Food & Drug Administration. The Company may use data from this or similar studies to support future FDA marketing applications.

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.

The ImmuKnow test is a qualitative assay and does not directly quantify the level of immunosuppression. Results of the ImmuKnow assay should be used in conjunction with clinical presentation, medical history, and other clinical indicators when assessing the immune status of any individual patient. The use of the ImmuKnow assay as described in this study has not been cleared by the FDA. The company may use data from this or similar studies to support a future FDA marketing application for a similar indication.

About Cylex, Inc.

Cylex is a privately held global life sciences company that is the leader in the development and manufacture of in vitro diagnostic products that are intended to illuminate immunity. ImmuKnow is the in vitro diagnostic utilized to detect cell-mediated immunity (CMI) in an immunosuppressed population, and is increasingly being adopted at organ transplant centers throughout the United States and abroad. The Company's patented technology provides an innovative platform allowing clinicians to simply and reproducibly assess CMI. The Company is based in Columbia, MD USA.


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