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Pablo Sanchez-Velasco and his colleagues in the Cantabria Health Systemand at the University of Cantabria, in Santander, Spain, used the CylexImmuKnow assay to prospectively monitor intracellular adenosine triphosphate(ATP) concentrations following CD4 cell activation as a measure of cell-mediated immune function in 81 immunosuppressed adults who underwent kidneytransplantation. The objective of their study was to examine the associationbetween cell-mediated immunity and risk for organ rejection (in under-immunosuppressed patients) or systemic infection (in over-immunosuppressedpatients). Their data were also compared to intracellular ATP levels in 52(non-transplanted) healthy controls.
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Their results demonstrated a clear correlation between intracellular ATPlevels for the healthy control group, a group of stable transplant patients,and infected transplant patients, with a statistically significant differencebetween the median ATP levels for these three groups:
These ATP levels correlate relatively closely to the three categories ofcell-mediated immunity defined for adult transplant patients in the product'spackage insert.
Only three patients in this trial underwent an acute rejection episodeduring the course of this study. The authors state that this was aninsufficient number of patients to validate the role of the ImmuKnow assay inmonitoring risk for organ rejection. The mean ATP level of the three patientswho underwent acute organ rejection was 247 +/- 193 ng/mL.
"We are pleased to see the data from this study support earlier publisheddata on the use of the ImmuKnow assay in monitoring adult patients after arenal transplant," stated Brad L. Stewart, president of Cylex. "Clearly thereis further research needed to elucidate the appropriate standards for use ofcell-mediated immunity to monitor risk for infection and rejection in selectedpatient categories. However, this publication further illustrates thepotential risks for infection associated with over-immunosuppression in renaltransplant patients, and the potential value of the ImmuKnow assay inmonitoring immune status."
*Sanchez-Velasco P, Rodrigo E, Valero R, et al. Intracellular ATPconcentrations of CD4 cells in kidney transplant patients with and withoutinfection. Clin Transplant. 2008;22:55-60.
About ImmuKnow(R)
ImmuKnow is the immune cell function assay cleared by the FDA to detectcell-mediated immunity (CMI) in adult patient populations undergoingimmunosuppressive therapy for organ transplantation by measuring theconcentration of adenosine triphosphate (ATP) released from CD4 cellsfollowing cell stimulation.
The ImmuKnow test is a qualitative assay and does not directly quantifythe level of immunosuppression. Results of ImmuKnow assays should be used inconjunction with clinical presentation, medical history, and other clinicalindicators when assessing the immune status of any individual patient. Theuses of the ImmuKnow assay as described in these studies have not beenapproved or cleared by the FDA. The Company may use data from these or similarstudies to support future FDA marketing applications for similar indications.
About Cylex, Inc.
Cylex(TM) is a privately held global life sciences company that is theleader in the development and manufacture of in vitro diagnostic productsintended to illuminate immunity. The Company's patented technology provides aninnovative platform allowing clinical researchers to simply and reproduciblymeasure immune cell function for the development of new diagnostics,biomarkers, and companion ass
