Studies validating performance of Pall prion reduction technology presented at AABB
East Hills, NY (October 17, 2005) - - Research studies demonstrating the effectiveness of prion filtration technology to safeguard the blood supply are being presented at the AABB Annual Meeting in Seattle, Washington today. Prion diseases, such as variant Creutzfeldt-Jakob Disease (vCJD), the human form of Bovine Spongiform Encephalopathy or "mad cow" disease, are of growing concern to blood services worldwide because of the potential for transmission through transfusion from asymptomatic donors. Pall Corporation (NYSE: PLL) is presenting research results further validating the performance of its Leukotrap® Affinity Prion Reduction Filter System, which was CE marked with a 99.9 percent prion removal efficiency in May 2005. It is the first technology that reduces infectious prions from red cells, the most widely transfused blood component.
A new study conducted by the American Red Cross and the Eastern Virginia Medical School, Norfolk Va., et.al., found that red blood cells filtered through the Leukotrap Affinity Prion Reduction Filter System retain their therapeutic value and quality after 42 days of storage. The samples tested showed mean values of 85.0 and 82.9 percent in vivo red cell recovery, exceeding the FDA required mean of 75 percent for stored red cells. Post-storage hemolysis (breakdown of red cell membrane) values were well below the FDA maximum limit. The researchers concluded that both in vivo and in vitro results of this study indicate that leukoreduced red cell products filtered through the Pall system demonstrated acceptable quality for transfusion.
Sam Coker, Ph.D., Principal Scientist of Pall Corporation, presented results of research testing the filter against sporadic CJD, the most common form of prion disease that affects humans. The study, conducted with the Departments of Neurology, Psychiatry and Pathology of the New York University School of Medicine, showed a 99.9 percent reduction of the prion.
"This study, a first with a true human form of prion disease, provides additional confirmation of the performance of our technology to remove all types of prions that can adversely affect people," said Dr. Coker. The sporadic CJD study is one of a series of studies underscoring the filter's capability in reducing all types of prions from blood, including scrapie (a prion disease affecting sheep) and mouse-adapted human vCJD.
Dr. Coker also presented the results of research on the performance characteristics of the Pall Leukotrap Affinity Prion Reduction Filter under a range of different blood processing conditions, which may vary by country and blood center. The results showed that the new filter was effective in removing infectious scrapie prions from different preparations of red cell concentrates at different temperatures. In addition to prion removal, the study also measured the level of leukocyte reduction (resulting in removal of about 5 logs) and the quality of red cells before and after filtration, showing that normal cell qualities were maintained.
Pall developed the Pall Leukotrap Prion Affinity Reduction Filter System to help blood authorities around the world stop the transmission of prions as part of the Company's mission to help safeguard the global blood supply. Its prion technology is currently under evaluation by the Irish Blood Transfusion Service and the English National Blood Service for integration into their respective practices as a blood safety measure to reduce the risk of vCJD prion transmission. Pall is continuing its prion research and development program to apply its technologies to meet the specific requirements of each nation throughout Europe, the epicenter of vCJD, followed by North America and Asia.
Source: Eurekalert & othersLast reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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