COLUMBIA, Md., May 30 /PRNewswire/ -- On Saturday, May 31 through Tuesday, June 3, at the annual American Transplant Congress (ATC) in Toronto, Canada, a total of 13 presentations will either report specifically on studies of the use of the ImmuKnow assay or will include information on the use of this assay in monitoring kidney, liver, and heart transplant patients over time.
Since it was initially cleared as an in vitro diagnostic technique to detect cell-mediated immunity (CMI) in adult patient populations undergoing immunosuppressive therapy for organ transplantation, understanding of the possible applications of the Cylex(TM) ImmuKnow assay (in clinical practice and in the clinical research setting) has continued to expand. Selected institutions are expected to issue their own detailed media information about individual studies (highlighted in bold type below). However, the full list of studies that is known to either focus on or include explicit reference to use of the ImmuKnow assay for CMI is as follows:
The various studies report on the clinical use of the ImmuKnow immune function assay in adult and in pediatric patients. The use of the ImmuKnow assay for identification of patients at risk for organ rejection and/or infection, as described in some of these studies, has not been cleared by the U.S. Food & Drug Administration (FDA). The company may use data from these or similar studies to support future FDA marketing applications.
About ImmuKnow(R)
ImmuKnow is an immune cell function assay that can detect cell-mediated immunity in adult patient populations undergoing immunosuppressive therapy for organ transplantation 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 used in conjunction with clinical presentation, medical history, and other clinical indicators when assessing the immune status of any individual patient. The ImmuKnow assay has not been cleared by FDA for assessment of immune cell function in pediatric patients.
About Cylex, Incorporated
Cylex(TM) is a privately held global life sciences company and a leader in the development and manufacture of research and in vitro diagnostic products intended to assist in the assessment of immune function. Cylex is the first and only company to offer a patent-protected in vitro diagnostic assay (ImmuKnow) used in the detection of cell-mediated immune function in immune-suppressed organ transplant patient populations. The ImmuKnow assay is increasingly being adopted for use by organ transplant centers throughout the USA and in other countries around the world.
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. The company is based in Columbia, MD.
CONTACT: Lynn Shepherd, +1-267-250-7376, lshepherd@voxmedica.com, or
Ketura Lispi, +1-215-925-9901, klispi@voxmedica.com, both of Vox Medica for
Cylex, Incorporated
