East Hills, NY (Oct. 31, 2005) - - At the request of the Food and Drug Administration (FDA) Transmissible Spongiform Encephalopathies (TSEs) Advisory Committee, Pall Corporation (NYSE: PLL) today presented the latest research results on its prion technology to remove TSE infectivity from blood. The Pall LeukotrapR Affinity Prion Reduction Filter system is the only Council of Europe (CE) marked technology shown to remove prions from red blood cells, the most commonly transfused blood component. Samuel Coker. PhD, Principal Scientist and Technical Director of Pall Medical, who has been spearheading the research effort, gave the Committee a first-hand look at the validation studies on the performance characteristics of the prion reduction technology filter that were used to earn its CE mark in Europe. He also presented new results on quality control measures for blood banks to use upon implementation of prion reduction as a means to prevent transfusion-transmitted variant Creutzfeldt-Jakob Disease (vCJD).
TSEs, also called prion diseases, are fatal neurodegenerative diseases that include vCJD, the human form of bovine spongiform encephalopathy (BSE), or "mad cow disease." The presentation, part of the Advisory Committee's discussion on labeling claims for TSE clearance studies for blood component filters, is a continuation of Pall Corporation's dialogue with U.S. regulatory and health authorities on protecting the blood supply from prions that can cause vCJD.
Studies Validating Filter Performance
Dr. Coker presented research results on the ability of the filter to remove all types of prions from red cells including scrapie (a TSE affecting sheep); mouse infected with human variant CJD (mvCJD) and human sporadic CJD (sCJD). Sporadic CJD is the most common form of CJD affecting people.
He provided results of bioassays to provide a quantitative method to determine log removal of infectious prion in hamsters. (Hamsters are recPage: 1 2 3 Related biology news :1
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