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Cylex ImmuKnow test may identify kidney transplant patients at risk for early acute rejection.

Cylex, Inc., Columbia, MD, announced that an independent, peer reviewed, clinical research study in which the level of cellular immune response measured prior to kidney transplantation using its proprietary ImmuKnow 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 study, which consisted 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. Cylex says a statistically significant correlation was reported between high pre-transplant levels of cellular immune response, as measured using ImmuKnow immune cell function test, and early acute transplant rejection as well as unstable kidney function within the first 90 days following kidney transplantation.

The results of study 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 in Los Angeles, CA. The article appeared in the February 15, 2008 issue of the journal Transplantation.

The authors of the article concluded 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."

Cylex says the ImmuKnow assay as described in the study has not been cleared by the FDA. The company does plan to provide data to the FDA at some point to support a marketing application for a similar indication.

Contact: Web site: www.cylex.net
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Publication:Transplant News
Date:Mar 1, 2008
Words:282
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