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Cooperative Diagnostics Pulls XMRV Molecular Test from Clinical Market

Discussion in 'XMRV Testing, Treatment and Transmission' started by George, Apr 5, 2010.

  1. George

    George Guest

    Cooperative Diagnostics Pulls XMRV Molecular Test from Clinical Market


    April 05, 2010



    By Kirell Lakhman
    Cooperative Diagnostics has voluntarily pulled its XMRV molecular assay from the clinical market due to the "controversial" claim linking the virus with chronic fatigue syndrome.


    The company launched the assay last October as a way to "assist physicians in the diagnosis of chronic fatigue syndrome and other disorders potentially caused by the virus." The test, which uses real-time PCR to detect the xenotropic murine leukemia-related virus, was also made available directly to patients.


    Cooperative Diagnostics' decision became noteworthy today after US regulators said the nation's blood supply could be at "potential risk" of being infected with XMRV.


    In a statement announcing the release of its XMRV assay last fall, Cooperative Diagnostics said the virus was "identified in 95 percent" of all patients with CFS, and in "large numbers" of patients with fibromyalgia and atypical multiple sclerosis.



    "When we learned that XMRV might have such a high association with chronic fatigue syndrome, we immediately became interested in developing a test," CEO Brent Satterfield said in the statement. "Now, [anyone] who has suffered from the condition can take testing for XMRV into their own hands."
    That was then. Today I noticed that Cooperative Diagnostics' web site says the company has stopped offering the test clinically, which cost $399 and was processed at Clinical Reference Laboratory. The test will be available for research use only.


    The link between XMRV and CFS "has been highly publicized by the media," causing "many people in the CFS community [to take] this information to mean that XMRV is most likely the underlying cause of the disease," Cooperative Diagnostics said in a sidebar of its XMRV FAQ page.



    It wasn't immediately clear when the notice appeared on the site, which also says "XMRV may or may not be present in the general CFS community, let alone be the cause."



    People with CFS, therefore, "may be better served by waiting for further studies connecting XMRV to CFS prior to investing in a diagnostic," the company says.


    As for the nation's blood supply, the Wall Street Journal today reports that "[e]fforts are under way to find effective tests for the virus and determine its prevalence, led by a working group funded by the National Institutes of Health and including federal agencies such as the FDA and the Centers for Disease Control and Prevention. Blood banks, academic institutions and at least one advocacy group are also involved."


    There is no FDA-licensed lab test for XMRV; "officials say they are still setting standards for diagnosing it," according to the Journal.
  2. Koan

    Koan Be the change.

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    Cooperative Diagnostics continues to be bad news for the the ME community. They rushed to offer a commercial test which did not work. They defended it without concern for the big picture. Now, they imply that the XMRV connection to ME is tenuous and not that they offered a useless test. I wonder if people who took it can get their money back if further testing proves it inadequate to the task.

    I understand that they were well intentioned, or so Kurt believes, but I'm so tired of these people!
  3. julius

    julius Watchoo lookin' at?

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    Add this little gem....

    "The test will be available for research use only."

    Gee, that should help move the science forward :rolleyes:.
  4. Robin

    Robin Guest

    So, they're saying they pulled their test because the "CFS claim" was controversial, not because their test was crap?

    I think the issue is culturing. We learned that from the Science paper (thanks, Gerwyn) and later from the interview with Goff:

    So maybe they just put out a standard PCR and just weren't finding it very often. Especially in small volumes of blood (can't remember how much they wanted.) In 8ml the WPI could only find it 1/4 tries. It seems like they really didn't think that it would be a big deal but obviously it's taking a long time for the HHS working group to come up with a standard test.

    My hope is for an FDA approved test that will be covered by Medicare...soon!!!
  5. Countrygirl

    Countrygirl Senior Member

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    :D:D:D
  6. Koan

    Koan Be the change.

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    :D


    I could be wrong, Robin, but I think they were the outfit requesting you send blood on a piece of paper, weren't they? Can anyone remember?
  7. George

    George Guest

    Yeah, 4 drops of blood on a paper mailing container. (giggles and grins) to find a tissue based retrovirus that clears the blood except for "extremely" low copies in T and B cells. I think they realized that this wasn't HIV with high numbers in the infected blood. You just can't find this virus the same way.
  8. VillageLife

    VillageLife Senior Member

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    Does anyone else think this week some very important people had some talks behind the scenes and since then things have started to change.
    1. Are starting to find it in the blood supply ?
    2. But there thinking hmm have we actual proof xmrv causes illness?
    - and so there not prepared to pull the blood supply to a halt, untill they know this xmrv actually makes you sick!

    (is that a possibility?)

    Well they don't want to throw good blood supply away and they don't want to cause panic however CFS can be a serious illness. You can end up un able to walk, feed your self and it's terrible!!! Or you might end up like myself *walking wounded* Able to live a very basic quality of life - Both are terrible. So I feel CFS is a serious enough illness to call this an emergency.

    The people get sick and never get well again. I call this serious and I call this a race against the clock to secure the blood supply is safe.
  9. Esther12

    Esther12 Senior Member

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    I've got that impression today, but we could well be reading too much into a few things. It could even be that they now don't think XMRV will be that much of a threat, and are planning a few final studies just to confirm that. Whatever the motivation it sounds like the study related to the blood supply, and involving the WPI, should let us know one way or the other, and relatively soon.
  10. VillageLife

    VillageLife Senior Member

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    Also GlaxoSmithKline got involved this week - so I think things changed this week.

    I think Cooperative Diagnostics, were told to pull there test.
  11. Gerwyn

    Gerwyn Guest

    so do i I did not know about the 4 drops on a piece of paper That is priceless!!
  12. Kati

    Kati Patient in training

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    Gerwyn, not priceless, it was 399$
  13. dannybex

    dannybex Senior Member

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    I thought they had pulled their test at least a month ago, if not earlier.

    d.

    p.s. Robin, I wouldn't hold your breath waiting for Medicare to cover any testing. I would think it would take at least a year or two...???
  14. garcia

    garcia Aristocrat Extraordinaire

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    This "test" should never have been on the market in the first place. Muppets.
  15. George

    George Guest

    And they don't take American Express! (snort, grin, chortle)
  16. Cort

    Cort Phoenix Rising Founder

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    That test doesn't look so good right now but I would note that they also took lots of blood from their study participants and looked very hard for it and apparently didn't find it or not much. We'll know how much when the study comes out.

    We're acting like they are idiots but none of the people in the game here- the researchers in any of the studies or the labs, etc. - are idiots. Based on the methodology in the Science paper (unactivated cells) and their confidence in their methodology they thought they should be able to find it.

    It wasn't until the WPI later said that the cells had to be activated and even then they had to take several passes over cells taken at different times from different patients sometimes that researchers heard how hard it was to find the virus.

    CD demonstrated that they could find XMRV in very low levels in samples but they didn't apparently find much of it (or any?) in CFS. For me, why is still a mystery.
  17. Gerwyn

    Gerwyn Guest

    the fact that the cells needed to be activated was clearly stated in the Science study.if they thought that they could find a gammaretrovirus using their "method" then they were idiots.

    There is no mystery their tests were useless. If anyone has instructions on how to perform a task,decides not to follow said instructions,subsequently fails at the task,then that person is an idiot!
  18. Cort

    Cort Phoenix Rising Founder

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    I'm sorry but I just really disagree with statements that professionals who make their living in a field are idiots in their chosen field.

    I still do not believe that it was 'clearly stated'; at best it was inferred and not well inferred. There was no statement indicating that the cells were activated in the PCR section. Despite your attempts to convince me otherwise I still think that was a very odd thing given that they clearly stated when activated cells were used elsewhere! (but chose to omit that fact in the PCR section?).

    More to the point I don't think any of these people are idiots and we run the risk of missing things if we simply discard them as such.

    Here are the tests CD offers. I think they generally know what they're doing. They seem to be as surprised as anyone else that their test didn't work out.
    [​IMG]


  19. Koan

    Koan Be the change.

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    Please Cort, at the very least they can be accused of hubris! They offered a commercial test for XMRV, marketed directly to people with ME/CFS, which relied on blood gathered on paper, within days of the release of research implicating XMRV in the illness.

    They rushed, they stumbled, they fell... that was certainly not smart.
  20. Gerwyn

    Gerwyn Guest

    Just because they make a living at something does not mean they are good at it.The science information re activation and amplification is clearly stated whether you believe it or not

    There was no PCR section as you put it.There were two PCR runs.in fact there were three! There were three seperate experiments.They did not use activation for fresh blood but did so from frozen.I,m suprised that you find it odd that they did not mention activation in the experiment where they did not activate the PMBs.mentioning activation in that experiment would be very odd and a major departure from scientific protocol!

    You may not think these people are idiots but they behaved idiotically in not following clear detailed instructions

    An idiot, dolt, or dullard is a mentally deficient person, or someone who acts in a self-defeating or significantly counterproductive way. ...

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