Katz webinar on XMRV Coming up on Thursday

Robyn

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He put up a picture of a set of scales. All the negative studies on the right, the 'Science' study on the left. The scales were even.

Then he alluded to the elephant in the room, the NIH/FDA study, and stuck an elephant onto the left hand scale and said that it was expected to be positive, but he did not know.
I bet the answer is already known in some agencies other than the NIH. But that's my guess.
 

V99

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I would have thought so.

I don't remember exactly how he said it.

They must be having so many meeting right now.
 

V99

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I really liked him. He just gave us the science, and avoided letting any emotions get in the way. He's a scientist!
 

Otis

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He put up a picture of a set of scales. All the negative studies on the right, the 'Science' study on the left. The scales were even.

Then he alluded to the elephant in the room, the NIH/FDA study, and stuck an elephant onto the left hand scale and said that it was expected to be positive, but he did not know.
I send a question along the lines of "without speaking about specifics, are you made aware of pre-publication data in order to react quickly to emerging pathogens?"

The answer was yes, which came to me directly in the question box, was "Yes". The response came from Kim, I think. I'm putting that elephant on the WPI side of the scales. Some of it was the tone of his voice. I get the feeling he'd be much more skeptical without that elephant.

But please Show Me The Paper. Please.
 

Robyn

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He said that he would have thought that they would have noticed if people were getting sick from the blood supply by now. But he seemed unsure when he said this.

I would add that the prejudices and ignorance around this disease is so severe that it is also likely they missed it.
Yes and there's the possibility that getting infected doesn't mean you get sick right away. Look at Hep C people could carry it for 20 years then get sick. And who really knows how long each of us have had the virus if it does turn out to be XMRV. I know my illness was triggered by a virus and I believe a weak immune system at the time. And then if someone did contract it from blood, they would most like be told they were just tired or depressed. There's too many variables I think.
 

Robyn

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WoW that sounds very good indeed!! could false positives be an issue at all. or not?? And what percentage do they find in healthy controls? Any news on that?
He could have been talking about the Science paper on the 90 percent. Sorry I wished I written down word for word. I don't recall anything about false positives coming up. The 3.7 in healthy controls was from the Science paper I believe. Nothing on recent healthy controls.
 

V99

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Yes and there's the possibility that getting infected doesn't mean you get sick right away. Look at Hep C people could carry it for 20 years then get sick. And who really knows how long each of us have had the virus if it does turn out to be XMRV. I know my illness was triggered by a virus and I believe a weak immune system at the time. And then if someone did contract it from blood, they would most like be told they were just tired or depressed. There's too many variables I think.
I agree ;)
 

V99

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The one other thing I remember is that he quoted from a couple Kerr studies. The gene expression study and this one:

“Studies of pathogenesis (of ME/CFS) have revealed immune system abnormalities and chronic immune activation, dysfunction of the hypothalamic-pituitary-adrenal (HPA) axis, brain abnormalities, evidence of emotional stress (comprising host aspects) and evidence of exogenous insults, for example, various microbial infections (Epstein-Barr virus, enteroviruses, parvovirus B19, coxiella burnetti and chlamydia pneumoniae), vaccinations and exposure to organophosphate chemicals and other toxins (comprising environmental aspects)” in patients with ME/CFS.” Devanur and Kerr (2006, p.139)
 

parvofighter

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Access to CLINICAL tests - how to facilitate this?

At least a year until a CLINICAL assay is ready for XMRV diagnostics?
Dr Katz gave a preliminary answer to one of my earlier questions about the process to translate analytical assays to clinical assays. As I recall, he initially said one year, then he gave more info on West Nile, said it took THEM a year, and that because XMRV was currently perceived with less urgency, it could take longer for us.

Can anyone answer any of the following questions I asked in the Amy Dockser Marcus thread: http://www.forums.aboutmecfs.org/sh...XMRV-Working-Group-Report&p=105519#post105519
Can anyone help out on this one? When will tests be available for actual patient use?
I'm still not clear (as per post #8) if/when the "winning assay(s)" to detect XMRV will be made available for clinical use. Keep in mind the terms of reference for this Working Group are ultimately focused on safety of the blood supply, not acceleration of access of diagnostics for patients. So my question remains: what is the process proposed (if there is one at all) to translate what this working group learns into bona fide tests available clinically? What is the process to approve and licence the tests (eg. FDA-approved), so that insurers will cover it, and other countries will adopt it? I am not at all certain whether the finding of a validated test automatically translates into its availability on the market. (NOTE: And Dr Katz's presentation would seem to support this) Does anyone know how long will this take? And how does this tie in with VIPDx plans for availability of the XMRV serology test?

Clinical vs analytical panels
Perhaps one of the sources of confusion is the discussion of clinical panels vs analytical panels. These panels are merely an array of samples of XMRV - the clinical ones blood from "real" infected patients; the analytical ones "spiked" normal blood or water with designated amounts of XMRV, against which the various labs will test their detection assays. An important differentiator for the real world is whether a lab can detect XMRV in a clinical panel (a proxy for a patient) - and what their detection threshold is. The CDC may well be able to detect XMRV in spiked analytical samples. But when presented with a sample of unstimulated blood from a bona fide ME/CFS patient, they may miss the elephant in the room with their assays. I totally agree with Sickofcfs that some face-saving may well be taking place with the Working Group's carefully worded line: "All the labs were able to detect at least some amount of XMRV". What is unsaid is that some labs (hazarding a guess here - the CDC?) may have to be hit over the head with XMRV to find it.

What are the rate-limiting steps before we have an available CLINICAL XMRV test?
Which brings me back to the crux of the matter. What are the steps before a validated test for blood safety purposes is translated to an available clinical test for us patients? I am not at all certain that a validated test for the Blood Working Group = a validated test for clinical use. Presumably we have to wait for patent processes, licencing and some commercialization. FDA approval? Other hurdles? How long might that take?...
Fostering a sense of urgency for availability of clinical tests for XMRV
Which raises my final question: What can we do to impress on the blood folks and other key stakeholders, the urgency for patients with ME/CFS to have diagnostics and clinical trials asap (in the event XMRV is found to be causal)? Which agencies/key contacts should we be directing educational/advocacy letters to?
 

Sasha

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parvofighter said:
Perhaps one of the sources of confusion is the discussion of clinical panels vs analytical panels. These panels are merely an array of samples of XMRV - the clinical ones blood from "real" infected patients; the analytical ones "spiked" normal blood or water with designated amounts of XMRV, against which the various labs will test their detection assays.
That's interesting, parvofighter - surely to protect the blood supply, they'd need a clinically effective test? After all, it's not a bunch of XMRV-spiked test tubes who will be turning up to blood donation centres to give their blood! Can they really afford to take a year to develop a test to protect the blood supply, let alone accurately diagnose people? Have I misunderstood what you meant?
 

VillageLife

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He said that they have to be really sure If xmrv causes illness, because they may have to pull 4% of blood donors and he said that 4% is enough to make a difference. He said they will need to Identify the 4% with a test.
 

parvofighter

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Partial answer

Hi Sasha, I wish I had taped the presentation. In response to your questions...
surely to protect the blood supply, they'd need a clinically effective test? After all, it's not a bunch of XMRV-spiked test tubes who will be turning up to blood donation centres to give their blood!
This is my sketchy understanding, and please if anyone can add to this, please do! My understanding of what Dr Katz said AND inferred is that there are actually 3 stages.

  1. Analytical assay - to see if XMRV can be detected in "spiked" normal blood or water with designated amounts of XMRV
  2. Donor Screening Assay - To screen donor blood for XMRV. From my notes on Dr Katz' presentation, these are usually DNA-based tests, eg. PCR. From what I understood it is not feasible to use these widely for the Diagnostic Assay
  3. Diagnostic Assay - The Holy Grail: what we're waiting for, to take to our docs and beg for treatment once causality is determined.
If I understood correctly it's the Diagnostic Assay that will take over a year. But the question remains whether a VIP serological assay (once available) - together with their other XMRV tests might be enough to get the ball rolling for the early adopters...?

Can they afford to wait? Can we afford to wait?
Can they really afford to take a year to develop a test to protect the blood supply, let alone accurately diagnose people?
THIS is where our advocacy/education efforts are needed, I believe. How can we facilitate this process?
 

Sasha

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Thanks, parvo - but doesn't WPI already have a diagnostic assay? I know that they're working with other labs to get a gold standard version (I thought Abbot pharma were involved) but is their version too expensive/involved to be practical for mass screening?
 

parvofighter

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Is it Validated?

Urbantravels nailed it: FDA approval.

Early adopters?
The part I'm not clear on is what can we DO with the forthcoming WPI assay?
For those of us with enlightened, educated physicians, the WPI test may be sufficient - together with our RNase-L deficiencies, NK cell dysfunction/numbers, documented opportunistic infections, etc - to consider at least more immunomodulatory therapies, and ARV's when indicated. It may be sufficient to encourage some physicians to look for gamma T-cell clonal rearrangements in long-term ME/CFS patients where there may be a suspicion of lymphoma risk. It may be enough to encourage leading-edge neurologists to do SPECT scans... My suspicion though is that the WPI test will be for the "early adopters", and that the majority of patients might need to wait for a government-validated test. Not that that's "right" or "fair"... may just be the way it unfolds.
The majority may have to wait??
But if I'm not mistaken, the majority of patients will still need to wait for an FDA-approved, government-validated test, before we get any financial coverage for this - or wider acceptance by less-informed physicians, of the test as "legit". Which underscores the importance of advocacy to educate the blood folks and other stakeholders on WHY this is urgent - from a scientific perspective.

And of course we have to wait for causality research. And the media response to XMRV - when embargos are finally lifted - may change the way things unfold.
 

dannybex

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Thanks, parvo - but doesn't WPI already have a diagnostic assay? I know that they're working with other labs to get a gold standard version (I thought Abbot pharma were involved) but is their version too expensive/involved to be practical for mass screening?
Yes...too complicated from what I gather. Seems to me some of the PWC's that sent their samples off to be tested had to be retested several times before they got a 'result' back.

???