* 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) will be presented on Dec. 14, 2010 to the BPAC. An agenda for the BPAC meeting can be found at http://bit.ly/ho5Aw4. BPAC meetings are open to the public, but are not available by webcast.
In this webinar, Graham Simmons, PhD, and Michael Busch, MD, PhD, of Blood Systems Research Institute and University of California-San Francisco will provide an update on the Blood XMRV Scientific Research Working Group studies, including results from Phase II, 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, will serve as moderator for the discussion.
The webinar is hosted by the CFIDS Association of America as part of its 2010 Webinar Series.