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Independent Studies Report on Possible Roles for Cylex's Immune Cell Function Assay in Monitoring of Heart and Lung Transplant Recipients

Six different studies will report on use of ImmuKnow assay in presentations at the annual meeting of the International Society for Heart and Lung


COLUMBIA, Md., April 9 /PRNewswire/ -- Since it was initially cleared as an in vitro diagnostic technique to detect cell-mediated immunity (CMI) in immune-suppressed adult patients, understanding of the possible applications of the Cylex(TM) ImmuKnow(R) assay (in clinical practice and in the clinical research setting) has been continuously expanding.

On Wednesday, April 9 through Saturday, April 12, at the annual meeting of the International Society for Heart and Lung Transplantation (ISHLT) Meeting in Boston, MA, an additional six presentations will report on studies of the use of the ImmuKnow assay in a variety of heart and lung transplant recipients:

Thursday, April 10

-- "Use of an immune monitoring assay to distinguish between fungal

colonization and fungal disease in lung transplant recipients"

(S. Husain, J. Pilewski, K. Spichty, et al.) -- oral presentation,

4:15 p.m. - 5:45 p.m. (Oral Session: Management of Emerging Infection

in Heart and Lung Transplantation)

-- "Immune cell function testing for the optimization of the therapeutic

drug monitoring in selected heart transplant patients, a case series"

(T. Ben Gal, V. Yaari, M. Israeli, et al.) -- poster presentation,

5:45 p.m. - 6:45 p.m. (General Posters: Poster Session II)

Friday, April 11

-- "Success of immune monitoring with ImmuKnow (Cylex) to assess

rejection/infectious risk in heart transplantation" (J. A. Kobashigawa,

K. K. Kiyosaki, J. K. Patel, et al.) - oral presentation, 10:45 a.m. --

12:45 p.m. (Oral Session: Can We Predict, Diagnose and Treat Cardiac

Rejection and Vasculopathy Before It's Too Late?)

-- "Assessment of the Cylex ImmuKnow cell function assay in pediatric

heart transplant patients" (J. W. Rossano, S. W. Denfield, E. O. Smith,

et al.) -- oral presentation, 10:45 a.m. - 12:45 p.m. (Oral Session:

The Long and the Short of Pediatric Immunosuppression and Immunology)

-- "Low Cylex immune response associated with increased infection in

pediatric heart transplants" (A. P. Barnes, S. M. Daneman, K. J.

Guleserian, et al.) -- poster presentation, 5:45 p.m. - 6:45 p.m.

(General Posters: Poster Session III)

-- "Monitoring for PTLD in children after lung transplantation"

(O. Elidemir, B. S. Kancheria, M. G. Schecter, et al.) -- poster

presentation, 5:45 p.m. - 6:45 p.m. (General Posters: Poster

Session III)

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 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 (CMI) in adult immunosuppressed patients 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 use of the ImmuKnow assay as described in these studies has not been cleared by the FDA. The company may use data from these or similar studies to support a future FDA marketing application for a similar indication.

ImmuKnow is a product of Cylex(TM), a privately held global life sciences company and the leader in the development and manufacture of research and in vitro diagnostic products intended to assist in the assessment of immune function.

About Cylex(TM) Inc.

Cylex(TM) is a privately held global life sciences company that is the leader in the development and manufacture of in vitro diagnostic products that are intended to illuminate immunity. ImmuKnow(R) is the in vitro diagnostic utilized to detect cell-mediated immunity (CMI) in an immunosuppressed population, and is increasingly being adopted at organ transplant centers throughout the US and abroad. The Company's patented technology provides an innovative platform allowing clinical researchers to simply and reproducibly measure CMI for the development of new diagnostics, biomarkers and companion assays. The Company is based in Columbia, MD.

SOURCE Cylex Inc.
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