FOI responses: XMRV testing by Molecular Diagnostics Unit, Imperial College, London

FOI responses: XMRV testing by Molecular Diagnostics Unit, Imperial College, London

Shortlink: http://wp.me/p5foE-2Pr

Update @ 11 March

In response to my querying the discrepancy between responses given under FOIA , ICL has responded:

“There is a slight distinction between the questions being asked and though it is the case that the test has been made available for researchers to test for any disease or condition, the patients for which the test is intended are those with prostate cancer, since it is the association of XMRV with this disease that the scientists are particularly interested in.”

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This mailing may be reposted provided it is published in full, unedited and https://meagenda.wordpress.com is credited as the source.

08 March 2010

In order to obtain clarification in relation to the advertising of XMRV testing by the Molecular Diagnostics Unit, Imperial College, London, three advocates submitted requests for information under the Freedom of Information Act (FOIA), in February.

Responses were fulfilled for all three on 08 March and are reproduced with kind consent of the recipients.

A copy of the complete text of the Molecular Diagnostics Unit, Imperial College, London XMRV Detection Testing web pages, which were taken offline on Monday, 8 February, has been archived on ME agenda site at this posting

Note my red highlighting of the inconsistancy between the response received by Suzy Chapman and the response received by Kim LeMoon in response to: “For what diseases/conditions/study domains is the XMRV test being made available to researchers?” and “If the XMVR Diagnostic Test was not being offered for people who are concerned that they might have CFS, or who have been diagnosed with CFS, what patient population was the test intended for?” and this is going to need further clarification.

R = Response by Imperial College, London Freedom of Information Office foi@imperial.ac.uk

[1] Request for information under FOIA by Suzy Chapman, UK:

To: Imperial College London, Freedom of Information Office
Date: 21 February 2010
Subject: XMRV testing available via ICL Molecular Diagnostics Unit (MDU)

A revised notice on the website for the MDU states:

“The MDU offers XMRV testing for research purposes only. If you are a researcher who is interested in XMRV testing, please contact the unit with an outline of your requirements.

“There has been some confusion around the availability of the XMRV test, for which we apologise. We would like to clarify that it is only available as part of an ethically approved research project. We emphasise that our laboratory does not deal directly with patients and we are not advising people who are concerned that they might have CFS, or who have been diagnosed with CFS, to request this test.”

On 6 February, The ME Association had published a notice on its website stating that it had been informed that an earlier announcement about XMRV testing on the MDU website:

“did not apply to people with ME/CFS, or suspected ME/CFS”

and that the test related only to:

“the availability of the Imperial College XMRV test to referring doctors who are dealing with cases of prostate cancer. A full clarification will appear on the Imperial College website on Monday.”

Although it has since been clarified by ICL that the XMRV testing being made available through the MDU is for researchers only, confusion persists over which diseases/conditions this test is being offered for.

I request the following information under the FOI Act:

1] For what diseases/conditions/study domains is the XMRV test being made available to researchers?

R: Further to your request for information regarding the diseases/conditions/study domains for which the XMRV test was made available to researchers (below) which was received by us on 22 February 2010, any physician or laboratory scientist can request the test for any disease or condition as part of an ethically approved research study. Our group at Imperial College London is currently focused on neoplasms of the genital tract but the clinical implications of XMRV infection are not yet fully understood. Our group is no longer studying CFS.

[2] Request for information under FOIA by Kim LeMoon, USA:

From: foi@imperial.ac.uk
Date: 08 March 2010
Subject: RE: Request for Information – XMRV Research

R: Further to your request for information received by us on 8 February 2010, please find below the College’s response to your questions.

Request for information under FOIA in respect of all ongoing research projects or scheduled research projects relating to XMRV (Xenotropic murine leukemia virus-related virus) detection via blood  samples, tissue samples or any other methods of detection

I should be pleased if receipt of this request for information could be acknowledged, together with the date by which a response will be provided.

Project Supervisors:

R: Professor Myra O McClure, Dr Steve Kaye, Professor Jonathan Weber

Project title:

R: XMRV and its association with Prostate cancer

Laboratory supervisor:

R: Dr Steve Kaye

Clinical supervisor:

R: Dr Anup Patel

1] Any Identification or Reference code assigned to Project:

R: n/a

2] Project’s Public Title; Project’s Scientific Title:

R: XMRV and its association with Prostate cancer

3] Study hypothesis/rationale (where applicable):

R: n/a

4] Ethics approval and any reference numbers attached to this approval:

R: Tissue bank ethics number 98CC141. A study to collect blood & urine specimens, prostate tissue &/bone marrow specimens to help establish methods for diagnosing and treating prostatic cancer.

5] Study design:

R: Molecular and serological methods

6] Countries of recruitment:

R: UK.

Centres of recruitment:

R: Imperial College Healthcare Trust.

Other methods of Recruitment:

R: n/a

* Through what means will prospective participants be recruited?

R: Signed consent to use biopsy tissue for retroviral analysis. Not yet underway.

7] For what diseases/conditions/study domains are patient samples to be collected?

R: Prostate cancer

* Through what means will control samples be assembled?

R: Not being assembled currently

8] Participants – inclusion criteria:

R: Participants will be restricted to those patients who are having a prostate biopsy for diagnostic purposes and have given consent for a small (10 micron) slice of their biopsy tissue to be used for research purposes.

9] Participants – exclusion criteria:

R: n/a

10] Target number of participants:

R: Open

11] Patient information material: please provide copies of any patient information material:

R: n/a

12] Anticipated start date:

R: January 2010

13] Anticipated project completion date:

R: December 2010

14] Sources of funding:

R: BRC [Ed: ICL has since clarified that “BRC” stands for Biomedical Research Centre ]

15] Sponsor details:

R: None

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[3] Addendum to Request for information under FOIA by Kim LeMoon, USA:

R: Further to the addendum to your request for information which was received by us on 8 February 2010, please find below the College’s response to your questions.

In addition to the earlier request that was made today, I request the following information under the Act

1] Principal Investigator(s):

R: Dr Otto Erlwein, Dr Steve Kaye, Professor Myra O McClure, Professor Jonathan Weber.

2] Names of Project Collaborator(s):

R: Dr Anup Patel

3] Names of Collaborating Institution(s):

R: Imperial College Healthcare Trust

From 27 Jan 2010 until 8 Feb 2010, XMRV Detection Testing was offered for £200 by the Molecular Diagnostic Unit via the Imperial College London website. On 8 Feb 2010, the information was removed from the website and replaced with this notification:

“We wish to apologise for any confusion concerning the availability of this test and would like to clarify that it is only available as part of an ethically approved research project. We emphasis that our laboratory does not deal directly with patients and we are not advising people who are concerned that they might have CFS, or who have been diagnosed with CFS, to request this test.”

Please provide answers to the following questions:

4] Why was the Molecular Diagnostic Unit charging £200 if the XMRV Diagnostic Testing is to be carried out as part of an ethically approved research study?

R: There are costs associated with providing this test. Therefore, if we are contacted by individuals from organisations outside Imperial requesting this test for a research study, we will charge them to test their samples.

5] Why was the XMRV Diagnostic Test being advertised to referring medical practitioners (GPs or hospital doctors) if the testing is being carried out as part of an ethically approved research study?

R: Medical practitioners such as GPs and hospital doctors are involved in research studies and we would expect any referring medical practitioner to be requesting samples as part of an ethically approved research study. We do not deal directly with patients.

6] If the XMVR Diagnostic Test was not being offered for people who are concerned that they might have CFS, or who have been diagnosed with CFS, what patient population was the test intended for?

R: Clinicians and clinical research scientists who are interested in the association of XMRV with prostate cancer.

[4] Request for information under FOIA by Julius, Canada

To: Imperial College London, Freedom of Information Office
Date: 09 February 2010
Subject: Request for information under FOIA in respect of Molecular Diagnostic Unit XMRV Test

Please acknowledge receipt of this request along with a Reference Number, and the date by which a response will be provided.

From 27 Jan 2010 until 8 Feb 2010, XMRV Detection Testing was offered for £200 by the Molecular Diagnostic Unit via the Imperial College London website.

Please provide information regarding the exact testing methods employed in the test offered including, but not limited to the following:

1) blood sample volumes and processing

2) does the test use a molecular plasmid control in water or a positive blood sample

3) primer sequences and amplification protocol used

R: Further to your request for information dated 9 February 2010 regarding the exact testing methods employed in XMRV testing carried out at the College (below) technical details associated with testing CFS tissue for the presence of XMRV are published in PLoS 1 January 6th 2010. Modifications of the assay for prostate cancer are not yet published and are not available to the public. The College hopes to publish this information before the end of the year.

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