Friday 29 August 2008

New Data Support Role For Monitoring Of Cell-Mediated Immunity In Adult Patients Following Renal Transplantation

�A of late published article by
Sanchez-Velasco et al. in Clinical Transplantation has expanded our
understanding of the clinical potential of monitoring cell-mediated
immunity in adult patients at risk of infection for organ rejection or infection
subsequent to kidney transplantation.



Pablo Sanchez-Velasco and his colleagues in the Cantabria Health System
and at the University of Cantabria, in Santander, Spain, used the Cylex
ImmuKnow assay to prospectively monitor lizard intracellular adenosine
triphosphate (ATP) concentrations next CD4 cell activation as a
measuring of cell mediated immune function in 81 immunosuppressed adults wHO
underwent kidney transplantation. The objective of their study was to
examine the association between cell-mediated resistance and peril for organ
rejection (in under- immunosuppressed patients) or systemic contagion (in
over-immunosuppressed patients). Their data were also compared to
intracellular ATP levels in 52 (non-transplanted) healthy controls.



Their results demonstrated a clear correlation between intracellular
ATP levels for the good for you control group, a group of stable transplant
patients, and septic transplant patients, with a statistically
significant difference betwixt the median ATP levels for these three
groups:


-- Infected transplant group (n = 24): mean ATP level = 197 +/- 114 ng/mL


-- Stable transplant group (n = 54): mean ATP level = 313 +/- 193 ng/mL


-- Healthy control group (n = 52): mean ATP level = 409 +/- 177 ng/mL




Only tierce patients in this trial underwent an acute rejection episode
during the line of this study. The authors state that this was an
insufficient number of patients to validate the part of the ImmuKnow assay
in monitoring risk for organ rejection. The hateful ATP level of the three
patients who underwent acute organ rejection was 247 +/- 193 ng/mL.



"We are pleased to see the data from this study support before
published information on the use of the ImmuKnow assay in monitoring grownup
patients afterwards a nephritic transplant," stated Brad L. Stewart, united States President of
Cylex. "Clearly in that location is further research needed to clarify the
allow standards for use of cell-mediated immunity to monitor risk for
infection and rejection in selected affected role categories. However, this
publication further illustrates the voltage risks for infection
associated with over-immunosuppression in nephritic transplant patients, and
the potential value of the ImmuKnow assay in monitoring immune position."



Sanchez-Velasco P, Rodrigo E, Valero R, et al. Intracellular ATP
concentrations of CD4 cells in kidney transplant patients with and without
infection. Clin Transplant. 2008;22:55-60.

About ImmuKnow(R)



ImmuKnow is the immune cell affair assay cleared by the FDA to detect
cell-mediated immunity (CMI) in adult patient populations undergoing
immunosuppressive therapy for organ transplant by measuring 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 ImmuKnow assays should be victimised
in conjunction with clinical presentation, aesculapian history, and other
clinical indicators when assessing the immune status of whatever individual
patient. The uses of the ImmuKnow assay as described in these studies have
not been approved or cleared by the FDA. The Company may manipulation data from
these or similar studies to living future FDA marketing applications for
similar indications.

About Cylex, Inc.



Cylex(TM) is a privately held global living sciences company that is the
leader in the development and manufacture of in vitro diagnostic products
intended to illuminate resistance. The Company's patented technology provides
an innovative platform allowing clinical researchers to simply and
reproducibly mensuration immune cell function for the development of new
diagnostics, biomarkers, and fellow assays. The Company is based in
Columbia, MD, USA.


Cylex(TM)
http://www.cylex.net



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