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News Release - April 24, 2009
An Independent Study Reports on the Utility of ImmuKnow(R), the Cylex(TM) Immune Cell Function Assay, for Monitoring Heart Transplant RecipientsThe results of the largest study performed to date will be presented during the International Society for Heart and Lung Transplantation Annual Meeting in Paris, France on April 24, 2009
COLUMBIA, Maryland, April 24 -- (Healthcare Sales & Marketing Network) -- Since it was cleared as an in vitro assessment of cell-mediated immunity in immunosuppressed patient populations, numerous clinical investigations have contributed to defining the role of the Cylex ImmuKnow assay among recipients of solid organ transplants.
In the largest immune monitoring experience in heart transplantation, investigators at UCLA's David Geffen School of Medicine followed 337 cardiac transplant patients with ImmuKnow to determine whether ImmuKnow assay values can be correlated with the incidence of infection or rejection.
The lead investigator, Jon Kobashigawa, MD, favorably remarked, "These results suggest that ImmuKnow as a non-invasive immune monitoring is indeed a promising means for individualizing immunosuppression in heart transplant recipients."
"This study expands our understanding of the applicability of the ImmuKnow immune function assay in effective management of heart transplant recipients in the post-transplant setting," stated Dr. Kobashigawa. Additionally, Kobashigawa and his colleagues conclude that the noninvasive ImmuKnow assay appears to predict infection with the promise of balancing risk of infection and rejection in heart transplant patients pending additional larger studies.
As described in this study, the use of the ImmuKnow assay for identifying patients at risk for infection or rejection following heart transplantation has not been cleared by the U.S. Food & Drug Administration. The Company may use data from this or similar studies to support future FDA marketing applications.
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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