XMRV Retrovirus: Round up 24: Testing and news of research studies

XMRV Retrovirus: Round up 24: Testing and news of research studies

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Click here for all previous XMRV Round ups and XMRV related postings in reverse date order

Testing for patients in the US

Whittemore Peterson Institute for Neuro Immune Disease: http://www.wpinstitute.org/

WPI Announces Availability of XMRV Testing

Press release: http://www.wpinstitute.org/WPI%20Release%20Diagnostic%20Test.pdf

VIP Diagnostics (VipDX): http://www.vipdx.com/

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Report from CFIDS Association of America

From the December edition of the CFIDS Association of America’s CFIDSLink e-newsletter:

HHS Coordinating Xenotropic Murine Leukemia Virus-Related Virus (XMRV) Scientific Activities

The U.S. Department of Health and Human Services (HHS) has formed an interagency scientific working group on XMRV. The Blood XMRV Scientific Research Working Group will report to the Department’s Blood, Organ and Tissue Senior Executive Council through established mechanisms. No formal statement has been issued yet, but the working group includes representatives from the DHHS Office of Public Health and Science, the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). The working group will have scientific responsibilities for investigation of XMRV as it relates to blood supply and CFS. Suzanne D. Vernon, PhD, the CFIDS Association’s scientific director, has been asked to participate in the XMRV scientific working group.

Dr. Jerry Holmberg of the HHS Office of Public Health and Science made a brief presentation on Oct. 30, 2009 to the DHHS CFS Advisory Committee. He described the existing response systems that address threats to blood safety, such as new and emerging infectious agents like XMRV. The HHS Blood XMRV Scientific Research Working Group will chaired by a representative of the NIH’s National Heart, Lung and Blood Institute (NHLBI) and will collaborate closely with the agencies in charge of these systems, including the NHLBI’s Retrovirus Epidemiology Donor Study (REDS). REDS was created in 1989 to address risks associated with HIV-1, HIV-2, HTLV-1 and HTLV-2 in the general blood supply.

In more recent communications with Dr. Holmberg, he stated that the Blood XMRV Scientific Research Working Group is taking a three-stage approach to its handling of the issues related to XMRV and the possible link to human disease. The first stage will be to standardize and validate laboratory methods and reagents for XMRV testing. This is important since variations in sample collection and laboratory procedures can produce discrepant results. These standardized approaches will be used initially to test 1,200 healthy donors’ blood samples and 100 CFS patients’ blood samples collected by Dr. Judy Mikovits of the Whittemore Peterson Institute. Stage two will assess the prevalence of XMRV in the general population and blood supply, as well as in other CFS patient cohorts. The third stage will be a series of studies to understand how XMRV is transmitted, whether it causes human disease, and how it affects various subgroups of the population.

The immediate focus is to ascertain any risks to the general blood supply that XMRV might pose, but the scientific working group is also addressing validation studies for diagnostic tests and if necessary, potential blood screening tests. If the studies indicate that screening is required for blood products, blood screening test, must be submitted to and approved by the FDA before they can be marketed. Neither of the tests currently being offered by two commercial labs has been reviewed by the FDA.

According to CDC, their studies using samples obtained from the Whittemore Peterson Institute has HHS attention. The Laboratory Branch in CDC’s Division of HIV/AIDS Prevention is doing the XMRV testing and not the CDC CFS research group in the Division of Viral and Rickettsial Diseases.

Representatives from the FDA attended the XMRV meeting sponsored by Abbott Laboratories at Cleveland Clinic on Nov. 11, 2009. Dr. Robert Silverman of the Cleveland Clinic gave a seminar about XMRV for HHS staff on Dec. 2, 2009.

Dr. Holmberg emphasizes the need for careful application of scientific methods to ensure that these studies are conducted with exceptionally high rigor and reliability so that the results provide a solid scientific foundation for moving forward. He understands the strong interest within the CFS patient community for swift action and definitive answers, and expressed the high priority that this subject is receiving within a broad range of functions within the Department of Health and Human Services.

The CFIDS Association will provide updates on these important activities as new information becomes available.

Links:
December edition of CFIDSLink:

http://www.cfids.org/archives/2006-2010-cfidslink/december-2009.asp

CFIDS Association’s XMRV Resources:
http://www.cfids.org/XMRV/default.asp#info

DHHS Statement on Blood Safety and Availability:
http://www.cfids.org/xmrv/blood-supply-ophs.pdf

NCI Q&A About XMRV:
http://www.cancer.gov/newscenter/pressreleases/XMRV_QandA

Summary of the October 2009 CFS Advisory Committee meeting:
http://www.cfids.org/cfidslink/2009/110401.asp

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Commentary

http://chronicfatigue.about.com/b/2009/11/26/chronic-fatigue-syndrome-news-xmrv-test-available-from-wpi.htm

By Adrienne Dellwo, About.com Guide to Fibromyalgia & CFS

Chronic Fatigue Syndrome News: XMRV Test Available From WPI

Thursday November 26, 2009

NEWSBRIEF: The Whittemore Peterson Institute (WPI) is now allowing a laboratory to temporarily offer the tests researchers used in the study linking XMRV to chronic fatigue syndrome (CFS or ME/CFS)…

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Testing for patients in the UK and Europe

http://www.xmrvtesting.co.uk/index.html

http://www.xmrvtesting.co.uk/UNITED_KINGDOM_XMRV_TESTING.htm

A member of the UK ME community is maintaining a site collating information on XMRV testing for patients in the UK and Europe.  (Note: I have no connection with this site and all enquiries should be directed to the site webmaster and not to ME agenda.)

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News of research studies

On 24 September, the Whittemore Peterson Institute announced news of a five year $1.6 million award

http://www.prohealth.com/library/showarticle.cfm?libid=14948  

NIH Bets $1.6 Million on Continued ME/CFS Research by Drs. Mikovits & Kerr
October 21, 2009

Dr. Judy Mikovits (principle investigator) and the Whittemore-Peterson Institute, with collaborator Dr. Jonathan Kerr, have been awarded a 5-year, $1.6 million grant from the NIH’s National Institute of Allergy and Infectious Diseases (NIAID) to support ongoing research into the disease mechanisms of chronic fatigue syndrome. Dr. Kerr is associated with St. George’s College in London.

The award was announced Sep 24 on the WPI website, before news of the CFS-associated XMRV retrovirus was published Oct 8 by the journal Science. A description of the project (# 1R01AI078234-01A2) is now included in the NIH’s Research Portfolio Online.

( http://projectreporter.nih.gov/reporter.cfm?CFID=7257406&CFTOKEN=97499939 )

Key Details from the NIH’s Project Description

• Title: “New Strategies to Decipher the Pathophysiology of Chronic Fatigue Syndrome.”

• Objective: “To provide significant insight into the disease mechanisms of Chronic Fatigue Syndrome so accurate testing and specific treatments can be developed with a goal of curing the disease and preventing life-threatening complications.”

• Timing: start date Sep 28, 2009; projected end date, Aug 31, 2014.

• Funding: First fiscal year funding $335,600; total funding $1.6 million.

• Project Description provided by applicant: (excerpt formatted for greater legibility, as follows).

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“Chronic Fatigue Syndrome (CFS) is a complex disease estimated to affect between 0.5%-2% of the population in the Western world.

Its pathogenesis is thought to involve both inherited and environmental (including viral) components, as with other chronic inflammatory diseases, such as multiple sclerosis, rheumatoid arthritis, and atherosclerosis.

Consistent with this chronic inflammatory context, CFS patients are known to have a shortened life-span and are at risk for developing lymphoma. We hypothesize that chronic inflammatory stimulation from active and recurrent infections of multiple viruses on a susceptible host genetic background leads to the pathogenesis characterized by CFS.

The overall goal of this research project is to define these viral and host parameters in European and American cohorts of CFS patients that correlate with distinct disease phenotypes, including the development of mantle cell lymphoma (MCL) in a subgroup of the American cohort.

In Aim 1) we will identify and confirm novel viral infections in European and American CFS patient cohorts.

1.1) We will use two complementary methods for detection of novel virus mRNA: massive parallel signature sequencing (MPSS) and a custom DNA microarray.

1.2) Quantitative polymerase chain reaction Q-PCR will be used for confirmation of virus gene expression.

1.3) Immortalized cell lines will be developed to isolate virus and elucidate links between virus and host cell gene expression.

In Aim 2), we will elucidate genetic factors of susceptibility and the dysregulation of the host defense system. Specifically, we will determine:

2.1) PBMC gene expression of 88 human genes previously confirmed as being differentially expressed in CFS

2.2) Serum chemokine and cytokine profiles using multiplex suspension antibody arrays on a Luminex platform

2.3) HLA, KIR genotypes and whole genome SNP profiles

2.4) Defects in the type I Interferon signaling pathway.

In each subaim both cohorts will be compared to normal and disease controls using specimens of serum and PBMC taken at multiple time-points from individual patients and taken from our unique and extensive sample repository.

This study:

• Will provide information necessary for development of treatment and diagnostic strategies for distinct subgroups of CFS patients,

• And may identify novel virus associations, genetic signatures, and biomarkers, which can predict the development of MCL, thus enabling use of preventive therapeutics.”….

For WPI Research Studies and Clinical Trials go here: http://www.wpinstitute.org/xmrv/xmrv_trials.html

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Dr Jonathan Kerr and Dr Derek Enlander

It has been widely reported on forums that Dr Jonathan Kerr (St. George’s University, London) and Dr Derek Enlander (New York) are also engaged in XMRV replication studies.

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XMRV researchers

According to an unofficial summary published by Dr Charles Shepherd on behalf of the ME Association following the APPG on ME meeting on 2 December:

“XMRV was discussed in some detail at the Medical Research Council Expert Group Workshop on November 19/20 where there were four UK researchers present who are actively involved in XMRV research:

• Dr Jonathan Stoye – National Institute for Medical Research
• Dr Kate Bishop – NIMR
• Dr Jonathan Kerr – St George’s Hospital
• Dr Suzanne Hagan – Glasgow Caledonian University

There are several other UK virologists involved with XMRV research as well – including Prof Greg Towers at University College London, whom CS recently met for an afternoon discussion.

So replication studies and other XMRV research is taking place, or is about to take place, here in the UK.

MERUK plus IRISH ME TRUST has just funded an XMRV replication study in Sweden.

The MEA Ramsay Research Fund has money available for UK studies – but money does not appear to be an immediate problem in the UK.

It looks as though there may even be some early results from replication studies before the end of the year.”

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Update: FOI request for information pending

University College London PhD project

http://www.findaphd.com/search/showproject.asp?projectid=18971

Dept/School Division of Infection & Immunity, University College London
Project Supervisor(s) Prof G Towers

Dr P Kellam
Funding Availability Competition Funded Project (European/UK Students Only)

A role for XMRV in human disease

Laboratory supervisor: Prof Greg Towers

Clinical supervisor: Prof Deenan Pillay

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Swedish XMRV study

http://www.meresearch.org.uk/research/projects/xmrvsweden.html

Prof Jonas Blomberg (Clinical Virology, University of Uppsala) and Prof Carl-Gerhard Gottfries (Sahlgrenska University Hospital, and the Gottfries Clinic) have just begun exploration of the relationship between XMRV and ME/CFS, with funding provided by ME Research UK and the Irish ME Trust

The results of this replication study are exxpected to be available in the Spring/Summer of 2010.

Related material:

ME Research UK overview essay: XMRV and ME/CFS – A stunning find

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Commentary on XMRV research and updates on studies

Thread on Cort Johnson’s Forums: http://forums.aboutmecfs.org/showthread.php?t=1349

Dr. Timothy Luckett: http://cfidsresearch.blogspot.com/

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Commentary and quality forums

Cort Johnson’s Phoenix Rising website: http://aboutmecfs.org/Rsrcs/XMRVResources.aspx

Cort Johnson’s Blog and comments: http://aboutmecfs.org/blog/

Cort Johnson’s Forums: http://forums.aboutmecfs.org/

Link Back

Whittemore Peterson Institute on Facebook

For initial Whittemore Peterson Press Release, NIH (National Institutes of Health) News Release, go here: http://wp.me/p5foE-272

For PDF reprint of Science paper go here:

http://www.sciencemag.org/cgi/rapidpdf/1179052?ijkey=m3wzKT4yJqEyk&keytype=ref&siteid=sci

Click here for all previous XMRV Round ups and postings in reverse date order: https://meagenda.wordpress.com/category/xmrv/

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