No donor screening for XMRV from the FDA. (I would have been surprised actually - I think they think they'll know soon enough about how to find the virus - then they'l make their decision).
The following note just arrived from Heidi Bauer, via the Blood Products Advisory Committee Meeting being held today, December 14, 2010. Thank you, Heidi:
“The Blood Products Advisory Committee has been asked to consider the issue of donor testing for MLV-related retroviruses even in the absence of confirmed disease causation. Absent evidence that these viruses have a causal role in any human disease it seems reasonable that the following criteria be met prior to the implementation of donor screening:
“1. evidence of transfusion transmission of these viruses
“2. consistent evidence of association of these viruses with disease, and
“3. development of validated assays for these agents that detect infected individuals but do not implicate non-infected individuals.
“The presence of a virus, and even transfusion transmission of an agent, is not, in and of itself a reason to implement donor referral or screening. Since no causal association of XMRV with human disease has been demonstrated, a decision to introduce a blood donor screening assay, were one to become available, would appear premature. Many commensal viruses, for example Anellovirus species, are known to be transmitted by transfusion but despite extensive study have not been associated with disease. In the absence of direct evidence of causation, a decision to implement testing should be based on an assessment of recipient risk that includes the prevalence of the infection in the donor population, the transmission rate to recipients and the current best assessment of the risk of recipient harm, compared to currently accepted risks of transfusion.
“Members of the blood transfusion community are concerned about the potential threat to the blood supply posed by XMRV/MLV and are actively involved in efforts to validate quality control panels and develop tests for the detection of MLV-related retroviruses. However we believe that current evidence does not support introducing any test methodology at this time.”
Is that Dr. Lombardi with Dr. Mikovits?? It looks like they are front and center - a good sign . I see Wanda! I think the woman in green she's talking to is the rep from the NIAID from the CFS Working Group. It could be Dennis Mangan next to them. Do I see a camera? Are they taping this?
XMRV post samles: blood collected into EDTA tubes by an independent phelbotomist at pts' home or work from the same 4 subjects (One patient had independently started ARV)
The pedigreed neg subject used for the analytical panel and phasse IIa panel was bled by the same phlebotomist a a control. Plebotomist directly supplied the samples to BSRI for processing. Samples separated into tubes and processed the same day, or left at 4 C for w2 days. Each sample processed into PBMC, WB & plasma.
Analysis -- blinded panels distributed by BSRI to WPI, CDC, NCI and Gen-Probe for testing. Two set of the panel were retained by BSRI to distrubte for follow-up work as neede. Results were reported back to BSRI and decoded.
Nothing startling here - they looked a different storage scenarios in 4 patients (only 4?) - then found who found what - that's the key part: did all the labs get the same results when they tested the sample?
I think Lo/Alter are up next - a most important presentation
Have they definitively determined where their mouse sequences came from? Mouse or man? Dr LeGrice said that was the next step for them. George and I just talked to retrovirologist who really worried about the Alter findings - because they were closer in sequence to endogenous retroviruses than XMRV. He would have expected the opposite - that they would have differed somewhat from XMRV and be further from mouse DNA. I had not heard that before.
This is critical for them....They did one contamination test but didn't do another more specific one. IF they can show their gene sequences have human DNA at the end of them they are in good shape...(ie if they were integrated into the human DNA instead of floating around in the blood)
A. Introduction and Background, Indira Hewlett, Ph.D., DETTD, OBRR, FDA (10)
B. Summary of Current Research on MLV-related Human Retroviruses and Disease Association, Jonathan Stoye, Ph.D., NIMR, UK ( 25)
C. Recent Studies of Epidemiology of MLV-related Human Retroviruses:
i. U.S. Study, Shyh-Ching Lo, M.D., OCTGT, FDA (15)
ii. U.S. Study. Maureen Hanson, Ph.D., Cornell University (15)
iii. UK Study, Judy Mikovits, Ph.D. Whitmore Peterson Institute (15)
D. Animal Studies: Potential Transfusion Transmission of MLV-related Human Retroviruses, Francois Villinger, Emory University (20)
E. Update of Blood XMRV Working Group Activities, Graham Simmons, Ph.D., BSRI (15)
F. Prospective and Retrospective U.S. Donor Surveillance Studies, Michael Busch, M.D., Ph.D., Blood Systems Research Institute (15)
G. Assay Development Efforts on MLV-related Human Retroviruses, Rachel Bagni, Ph.D., National Cancer Institute (20)