Cylex Announces FDA Clearance for Immune Function Assay.Business Editors/Health & Medical Writers BIOWIRE2K NOTE TO MEDIA: Photo is available in a Smart News Release(TM) on Business Wire's Home Page at www.businesswire.com and at www.newstream.com COLUMBIA, Md.--(BW HealthWire)--April 9, 2002 Cylex,(TM) Inc., a privately held, venture-capital backed life sciences company, announced today that it has received FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. clearance for the Cylex(TM) Immune Cell Function Assay. The assay is used to measure the immune response of patients receiving immunosuppressant therapy for organ transplantation and is the first product cleared by the FDA for measuring global cell-mediated immunity. "This clearance is not only a major milestone for the company but physicians now have a method that allows them to rapidly assess an individual patient's immune status at any point in time," explains Cylex President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. Judith A. Britz, Ph.D. According to Dr. Adriana Zeevi of the University of Pittsburgh, Thomas E. Starzl Transplantation Institute, "The Cylex Immune Cell Function Assay can be considered as an in vivo bio-assay for drug activity and should be used as an adjunct to drug level monitoring post-transplantation along with other clinical indicators." The assay measures the concentration of ATP ATP: see adenosine triphosphate. ATP in full adenosine triphosphate Organic compound, substrate in many enzyme-catalyzed reactions (see catalysis) in the cells of animals, plants, and microorganisms. from circulating CD4+ cells following in vitro stimulation with phytohemagglutinin phytohemagglutinin /phy·to·hem·ag·glu·ti·nin/ (-hem?ah-glldbomact´in-in) a hemagglutinin of plant origin. phy·to·he·mag·glu·ti·nin n. Abbr. (PHA PHA abbr. phytohemagglutinin PHA phytohemagglutinin, a plant lectin. ) as an indicator of immune function. Ronald Hahn of Early Stage Enterprises, LP, the lead venture capital investor in Cylex, commented that FDA approval is the first step in establishing the Cylex(TM) platform technology as the standard for measuring immune system functionality in a wide range of applications. The Cylex(TM) Immune Cell Function Assay was designed for the clinical market and improves upon currently available research methods because it is easy to perform, results are available within 24 hours rather than several days, and it uses only a small amount of whole blood. The use of whole blood as the sample is especially beneficial since the most widely used immunosuppressive drugs are found in red cells. This allows the assay to mimic the in vivo response the patient is experiencing from the drug therapy. Clinical trials were conducted at the University of Pittsburgh Medical Center The University of Pittsburgh Medical Center (UPMC) is a leading American healthcare provider and institution for medical research. It consistently ranks in US News and World Report's "Honor Roll" of the approximately 15 best hospitals in America. , University of Alabama The University of Alabama (also known as Alabama, UA or colloquially as 'Bama) is a public coeducational university located in Tuscaloosa, Alabama, USA. Founded in 1831, UA is the flagship campus of the University of Alabama System. , Birmingham, and the University of Maryland Biotechnology Institute “UMBI” redirects here. For the Japanese Marine Biological Institute, see Usa Marine Biological Institute. Formed in 1985, the University of Maryland Biotechnology Institute (UMBI) is part of the University System of Maryland. , the Institute of Human Virology The Institute of Human Virology (IHV) at the University of Maryland School of Medicine is a world-class center of excellence focusing on chronic viral diseases, most notably HIV/AIDS, and virally linked cancers. IHV was founded in 1996 and continues to be directed by Dr. Robert C. . Cylex(TM), Inc. is a bioscience company dedicated to developing products that allow physicians to more effectively manage immunosuppressed patients and determine the efficacy of their therapy by measuring immune cell function. Cylex's patented technology provides an innovative approach for measuring immune activity in transplant, AIDS, and cancer patients, those with other infectious diseases and autoimmune disorders. It is expected that the technology will also be a valuable adjunct in the development of new drugs including vaccines, therapeutics and nutriceuticals which impact the immune system. Inquiries regarding the Company should be sent via e-mail to contact@cylex.net. Additional information is available on the Company's web site at www.cylex.net. Note: A Photo is available at URL: http://www.businesswire.com/cgi-bin/photo.cgi?pw.040902/bb10 |
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