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Published on Dec 20, 2010
The Department of Health and Human Services Blood XMRV Scientific Research Working Group (SRWG) was established in late 2009 to design and coordinate research studies to evaluate whether XMRV poses a threat to blood safety. It is presently overseeing a four-phase study with the following objectives: - Phase I: Evaluating the analytical sensitivity of multiple XMRV nucleic acid assays - Phase II: Pilot clinical studies to evaluate optimal processing time and sample preparation - Phase III: Evaluating clinical sensitivity and specificity of XMRV nucleic acid and antibody assays - Phase IV: Initial estimation of the proportion of blood donors who are positive for XMRV nucleic acids and/or antibodies.
Results of the Phase I (analytical panels) were presented on July 27, 2010 at a meeting of the FDA's Blood Products Advisory Committee (BPAC). Results of Phase II (pilot clinical studies) were presented to BPAC on Dec. 14, 2010.
In this webinar, Graham Simmons, PhD, and Michael Busch, MD, PhD, of Blood Systems Research Institute and University of California-San Francisco provide an update on the Blood XMRV Scientific Research Working Group studies, including results from Phase IIa and IIb, as well as future retrospective repository and prospective screening studies of XMRV in US blood donors and recipients. Steven H. Kleinman, BSc, MD, of University of British Columbia, and a member of the SRWG, serves as moderator for the discussion. The panel explains the findings, shares a timeline for past steps, and addresses questions submitted by registrants.