New Independent Research Study Indicates That Cylex's ImmuKnow Test May Identify Kidney Transplant Patients At Risk For Early Acute Rejection

Main Category: Urology / Nephrology
Also Included In: Transplants / Organ Donations;  Immune System / Vaccines
Article Date: 21 Feb 2008 - 0:00 PDT

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Cylex, Inc., announced the publication of an independent, peer reviewed, clinical research study in which the level of cellular immune response measured prior to kidney transplantation using the Company's proprietary ImmuKnow(R) immune cell function test was found to identify patients that may be at risk for early acute transplant rejection and unstable kidney function in the first three months following transplantation.

The results of this independent clinical research study, which was authored by members of the kidney transplant programs at Duke University Medical Center (Durham, NC), the University of Minnesota (Minneapolis, MN) and Cedars-Sinai Medical Center (Los Angeles, CA), appeared in an article published in the February 15, 2008 issue of the journal Transplantation.

"Based on our immunosuppression protocol, this study is the first to show that high pre-transplant ImmuKnow values identify recipients at risk for early acute rejection and unstable renal function," said Dr. Nancy L. Reinsmoen of Cedars-Sinai Medical Center and the lead author of the study. "No other innovative parameter we tested showed any such trends or associations."

This study of 126 kidney transplant patients was designed to evaluate the association of a number of immune parameters measured prior to kidney transplant with the occurrence of early acute rejection, unstable kidney function and graft outcome following transplantation. A statistically significant correlation was reported between high pre-transplant levels of cellular immune response, as measured using the ImmuKnow immune cell function test, and early acute transplant rejection as well as unstable kidney function within the first 90 days following kidney transplant.

The authors of the Transplantation article conclude that pre-transplant assessment of donor-specific and nonspecific immune parameters with ImmuKnow "may identify recipients who can benefit from closer clinical and immunological surveillance to allow for tailored immunosuppression and selective intervention aimed at optimizing both short and long-term graft outcome."

"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 immune cell function for the development of new diagnostics, biomarkers and companion assays.

Cylex, Inc.
http://www.cylex.net