Cylex(TM) Receives ISO 13485:2003 and 9001:2000 Quality Cert... (roval to sell a medical device and there...)

Cylex(TM) Receives ISO 13485:2003 and 9001:2000 Quality Certifications

Date:9/30/2008

roval to sell a medical device and therefore supports the Company's plans to market its ImmuKnow immune cell function assay to customers around the world.

About ImmuKnow(R)

ImmuKnow is the immune cell function assay cleared by the FDA to detect cell-mediated immunity (CMI) 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.

About Cylex, 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 intended to illuminate immunity. 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. Cylex has received certification to ISO 13485:2003 and 9001:2000 for its quality system for "design and development, manufacture and distribution of in vitro diagnostic products related to immune function testing". The Company is based in Columbia, MD USA.

SOURCE Cylex
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Cylex(TM) Receives ISO 13485:2003 and 9001:2000 Quality Cert...(roval to sell a medical device and there...)