Sunday, 24 August 2008

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

�A 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 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 intracellular adenosine
triphosphate (ATP) concentrations following CD4 cell activation as a
amount 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 immunity and risk for hammond organ
rejection (in under- immunosuppressed patients) or systemic infection (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 betwixt intracellular
ATP levels for the goodish control mathematical group, a group of stable transplant
patients, and infected transplant patients, with a statistically
meaning difference betwixt the average ATP levels for these three
groups:


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


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


-- Healthy control radical (n = 52): beggarly ATP horizontal surface = 409 +/- 177 ng/mL




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



"We ar pleased to see the data from this study support to begin with
published data on the use of the ImmuKnow assay in monitoring adult
patients later on a nephritic transplant," declared Brad L. Stewart, president of
Cylex. "Clearly there is farther research requisite to shed light on the
seize standards for use of cell-mediated immunity to monitor risk for
infection and rejection in selected patient categories. However, this
publication further illustrates the potency risks for infection
associated with over-immunosuppression in renal transplant patients, and
the potential economic value of the ImmuKnow assay in monitoring immune condition."



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 function assay clear by the FDA to detect
cell-mediated immunity (CMI) in adult patient populations undergoing
immunosuppressive therapy for organ transplantation by measure the
assiduousness 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 secondhand
in conjunction with clinical presentation, aesculapian history, and other
clinical indicators when assessing the immune status of whatsoever individual
patient. The uses of the ImmuKnow assay as described in these studies get
not been approved or cleared by the FDA. The Company may use data from
these or similar studies to support future FDA marketing applications for
similar indications.

About Cylex, Inc.



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


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



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