Newly refined test from the Whittemore Peterson Institute

[Cort]

My take on this is that they backing way off the PCR test. I don't know how else to read it.

Culture In/PCR Out - Oddly enough, they said that the culture test is "the only scientifically validated methodology to find XMRV" which puts into question the validity of the PCR test. In fact, the message indicates the WPI is backing away from the PCR test, heretofore, the main focus of validation efforts, stating "At this time no single PCR or whole blood assay alone has been validated as accurately detecting XMRV, and is therefore not an appropriate way to study or diagnose the presence of the virus."

This means that your PCR tests, while certainly not meaningless, are not diagnostic yet. This is quite a change. XMRV is a new bug whose genetic variation from place to place is unknown; until more is known regarding how XMRV differs from location to location its going to be impossible to create a 'validated' test for it. The DHHS in cooperation with several labs is reportedly doing the work.

 

[MEKoan]

Hi Kurt,

What I don't get is why you were so supportive of the Cooperative Dx test, which, if proven reliable, would have the problems you articulate here, but are consistently critical of WPI.

I'm confused.

from October 29th, 2009 08:07 PM

Also of interest, Dr Satterfield helped with rapid Anthrax test development, I don't know the details but can find out if anyone wants. I have suggested to them that they need to communicate better their capabilities and credentials. They are a young firm and I believe they are exactly what we all hoped would happen after the WPI announcement, highly capable scientists in industry becoming interested in CFS. And they are committed to CFS, not just XMRV, I think we will be seeing much more of their work in the near future. They have mentioned to me that they are involved in a study and hope to have a journal publication out relatively soon.

The comments of Dr Peterson are understandable as this is competition for his testing (the VIP lab is probably paying a hefty licensing fee back to WPI). But I think it is unfortunate that such acclaimed scientists would so rapidly dismiss the very thing we need in the CFS world, the growth of services for people with CFS. They should not be afraid of a little competition.

Based on what I know there is nothing to fear from purchasing the XMRV testing from Cooperative Diagnostics. I wish more people would do their homework here. Just read the bio on Dr Satterfield, on their website for the details of their capability. This is a serious group that wants to make a difference and is applying their expertise, just as WPI has done for us. In fact, we have rarely had Ph.D. biomedical engineers that capable interested in CFS, I know of no others. I hope we do not chase them away before they have had a chance to make the difference that they can, they might produce answers other firms can not, as they are committed to diagnostic testing and have unique capabilities in that area.

 

[dsdmom]

Am I missing something? I saw this earlier on facebook and read it again above - maybe it's my brain just not working - but I don't see any reference to a *new* test. All they seem to be doing is explaining in more detail the differences between the tests they have developed and the one used in the UK and others.

Seriously - what I am missing?

 

[kurt]

Hi Kurt,

What I don't get is why you were so supportive of the Cooperative Dx test, which, if proven reliable, would have the problems you articulate here, but are consistently critical of WPI.

I'm confused.

from October 29th, 2009 08:07 PM

Koan,
LOL, are you baiting me?

When I see problems with Cooperative I post that, and also talk to my contact there. I still believe the Cooperative test is/was accurate, for what they test. They are using a different type of PCR test, a computational real-time PCR test. That test does have risks which I have posted about (you would have to look I don't recall which posts, sorry). For example, RT-PCR has a greater risk of false negative than the standard PCR used by WPI. The WPI PCR and culture/antibody tests have a higher risk of false positive. I think WPI now realizes that there are problems with PCR testing for XMRV, that might explain why they are re-focusing on the more general MuLV antibody tests (the culture study uses WB antibody testing).

Cooperative is a PCR test development company with capabilities well beyond WPI, in that narrow domain. That was why I was so excited about them becoming interested in CFS. But that is all they are, Cooperative does not have the medical depth of WPI, they are just focused on international testing of difficult pathogens. Based on their experience finding difficult pathogens they focused on the pol gene initially, one that does not change (if it does the virus can not replicate and goes extinct). That seemed like the broadest approach, and they expected to find even more XMRV than the WPI test. So their test in some ways is more direct for XMRV, or any MuLV pathogen.

My problems with WPI testing are mostly the risks of the type of testing they are using, and the claims they are making that seem to go beyond what they have actually proven. That's the summary anyway. I like the fact that WPI wants to help PWC, and am totally enamored by their virachip study (which really should be replicated). I have posted that also a lot, but for some reason people seem to highlight the critical statements. Sigh.

Also, being critical is part of the scientific process. That is sometimes how explanations are found. For example, working over the issues, I learned many HERVs (endogenous retroviruses) have deletions. For example they could lack a pol gene and still survive in the host DNA. Therefore, if WPI actually is finding HERV type II activation in CFS (that is a HERV that is similar to MuLV), and if that HERV is missing a pol gene, PCR tests for the pol gene would not find it. And WPI is only testing gag and env genes. This is just an example, I am not proposing this is happening, just pointing out that unlike ME/CFS advocacy, in research being critical is essential. Advocacy and research just do not mix well. So seeing WPI mix them just does not sit well with me.

--Kurt

 

[Smulan]

Thanks for posting that.

cut

" They are acting like their test is a gold standard, and that is highly premature, even if they are correct."

If they are correct I think thats exactly the way they should act.

cut

"4. As with the prior XMRV tests, there is no real guidance for patient or physician. What does one do with the results of this test? Since WPI is selling so many XMRV tests, what do they expect people to learn, how will this help my ME/CFS? I think that small problem is being ignored in all the excitement. Again, if WPI wants to be a CFS advocacy company, then please advise us of the reason we need to be tested for XMRV at this time."

cut

Well I think its up to you and me to decide if we wont to get tested at this time. WPI has already stated that they dont * know* what xmrv does to a person but one reason could be to minimize risk of transmisson.

.[/QUOTE

reply in the quote above.

 

[kurt]

Am I missing something? I saw this earlier on facebook and read it again above - maybe it's my brain just not working - but I don't see any reference to a *new* test. All they seem to be doing is explaining in more detail the differences between the tests they have developed and the one used in the UK and others.

Seriously - what I am missing?

It appears VIP Dx is about to offer the culture test as a separate testing product. This will presumably be much lower cost. So it is not a new test, but rather a new product split off from the $650 package.

 

[kurt]

Thanks for posting that.

cut

" They are acting like their test is a gold standard, and that is highly premature, even if they are correct."

If they are correct I think thats exactly the way they should act.

cut

"4. As with the prior XMRV tests, there is no real guidance for patient or physician. What does one do with the results of this test? Since WPI is selling so many XMRV tests, what do they expect people to learn, how will this help my ME/CFS? I think that small problem is being ignored in all the excitement. Again, if WPI wants to be a CFS advocacy company, then please advise us of the reason we need to be tested for XMRV at this time."

cut

Well I think its up to you and me to decide if we wont to get tested at this time. WPI has already stated that they dont * know* what xmrv does to a person but one reason could be to minimize risk of transmisson.

.[/QUOTE

reply in the quote above.

Good comments. Yes, if they are correct they should act that way. But that is not proven yet, one published study is not enough evidence to demonstrate they are correct.

Minimizing transmission risk? Hmmm, I had not thought of that as a reason to test, but I agree, if one suspects XMRV really is a danger. However, I have been married throughout my CFS case and my wife did not 'catch' CFS, over 14 years now. And I know many other PWC in a similar situation, I tested negative already for XMRV, but definitely have classic CFS. Anyway it just gets complicated. Also, I seriously doubt that is the reason most people are getting tested, but perhaps a few.

 

[Alice Band]

Hi Kurt and all.

These were the original tests offered by VIP when I first spoke to them

XAND by PCR for XMRV active infection ($400)
XAND1 for virus culture for XMRV latent infection ($500)
XAND 2 (both for 650)

Coming soon

XAND with Western Blot (Reflexive) as confirmation of the XMRV active infection
XAND by serology : Serological assay for XMRV IgG will be available shortly

======================

What I am missing is how the new test is new. I appreciate all the discussion here, critical and not. It may be that we cannot tell if this test is new, repackaged or they are just offering the same culture test as they have been offering so far but without being bundled to the PCR which it is now.

 

[wornout]

Something I think we all should remember

Cooperative Diagnostics, LLC was the first lab to offer the XMRV test to the public.

I don't think they are involved with the WPI or their research but they saw the chance to make money from the publics demand for a test for XMRV.

I see the WPI's response to the publics demand for a test as appropriate. They are able to satisfy the public's demand and reinvest the money into research to develope a better test for XMRV

Does anyone remember Dr. Defreita's research? Perhaps if she had better PR her research may have led somewhere and not been stopped because of lack of funding.

Maybe we should be looking for two retrovirus?

 

[fresh_eyes]

For example, working over the issues, I learned many HERVs (endogenous retroviruses) have deletions. For example they could lack a pol gene and still survive in the host DNA. Therefore, if WPI actually is finding HERV type II activation in CFS (that is a HERV that is similar to MuLV), and if that HERV is missing a pol gene, PCR tests for the pol gene would not find it. And WPI is only testing gag and env genes.

Hi Kurt. This is an interesting thought. So the WPI could be picking up a HERV that resembles XMRV, but lacks certain of its genes, and among those are the ones the UK scientists looked for. I know you are not suggesting this is what's happening, but if it were happening, it would be 98+% HERV activation in CFS vs. 3.7% in controls, which would indicate this HERV activation as a biomarker at the least for CFS, possibly even causal. It's the first thing I've heard, apart from fatally flawed techniques in one lab, that could possibly explain the drastically different results in the US & UK studies.

 

[kurt]

Originally Posted by Kurt View Post
For example, working over the issues, I learned many HERVs (endogenous retroviruses) have deletions. For example they could lack a pol gene and still survive in the host DNA. Therefore, if WPI actually is finding HERV type II activation in CFS (that is a HERV that is similar to MuLV), and if that HERV is missing a pol gene, PCR tests for the pol gene would not find it. And WPI is only testing gag and env genes.

Hi Kurt. This is an interesting thought. So the WPI could be picking up a HERV that resembles XMRV, but lacks certain of its genes, and among those are the ones the UK scientists looked for. I know you are not suggesting this is what's happening, but if it were happening, it would be 98+% HERV activation in CFS vs. 3.7% in controls, which would indicate this HERV activation as a biomarker at the least for CFS, possibly even causal. It's the first thing I've heard, apart from fatally flawed techniques in one lab, that could possibly explain the drastically different results in the US & UK studies.

Wouldn't that be interesting? I had the same thought about the Cooperative testing as they test the pol gene. However this would probably have to be an undiscovered HERV, otherwise the researchers would have picked it up in their genbank searches. So might be hard to track down. This possibility is one of the reasons I have been studying the WPI virachip study, because the virachip study showed high HHV levels in CFS, and some HHV viruses are known to activate HERVs. Someone is going to figure this out, this might be a rough outline of what is really happening, but that is pretty hard to guess right now.

 

[fresh_eyes]

This possibility is one of the reasons I have been studying the WPI virachip study, because the virachip study showed high HHV levels in CFS, and some HHV viruses are known to activate HERVs.

Do you have a link to that study?

 

[Alice Band]

Does introducing a Western Blot test get around any of the problems mentioned in the critiques of the testing methods?

I did ask VIP in December and they thought it would be available by February

 

[Hope123]

Do you have a link to that study?

Yes, I'd like that link as well. Have heard of study, haven't read it.

 

[parvofighter]

This thread is on fire! Thanks, @ Abraxas and Kurt for your great insights and in-depth analysis. Geez, "attending" this forum is like going to university. A constant learning curve!

OK, this is the part I find really interesting - for what WPI doesn't say, or maybe what they can't say. And since I'm a betting person, and admittedly a confessed XMRV optimist, I'll make a wager, with a promise to put up an avatar (for a week), of egg-on-face if I'm wrong. Here's the bait:

​

My gut tells me that the wording of the WPI press release is coyly skirting around the issue of what the SAM HILL the Health & Human Services Blood Review (with Jerry Holmberg) has been up to!

Here's my bet: I think WPI and the Blood Review HAVE validated and improved the virus culture test for XMRV. Specifically, they HAVE validated the test at MULTIPLE labs - above and beyond NCI and the Cleveland Clinic. And we won't hear this officially until the formal Blood Review announcement (whenever that is).
​

Take a look at Abraxas' post:

The testing method, validated in multiple other labs using positive control samples, uses a unique process that was extensively peer reviewed before publication and provides the most accurate results available.

This virus culture test is the same method used in the Science publication, and the only scientifically validated methodology to find XMRV. Some labs, including the recent study published in the U.K., have used non-validated PCR and whole blood PCR assays. At this time no single PCR or whole blood assay alone has been validated as accurately detecting XMRV, and is therefore not an appropriate way to study or diagnose the presence of the virus....WPI has licensed the latest version of the test to Viral Immune Pathways Diagnostic Laboratories (VIP Dx) in Reno, Nev. The non-exclusive license allows patients and their doctors access to a reliable diagnostic tool. The newly refined test uses a virus culture methodology that yields more reliable results in one test at a lower cost to patients.
​

OK, why would WPI say, "validated in MULTIPLE other labs?". Why would they bother releasing a test that hasn't stood up to the rigors of Jerry Holmberg's SWAT Team, when it might be rendered redundant as soon as Holmberg releases HIS test? I think these are one and the same. Yes, WPI has have been a tad awkward with some of its handling of the press. But my Spidey Senses are tingling on this one, because in their scientific work, their use of words has been very precise. My gut tells me that "validated in multiple other labs" isn't political hyperbole. If anything, it's political coyness and journalistic discretion.

Consider: the original Science paper only validated the results in 2 other labs: Cleveland Clinic, and NCI. Remember that all along, the WPI and the Science team have been intimately involved with Dr Holmberg's Stealth multi-agency team. They haven't been twiddling their thumbs.

So Kurt, you were right on the mark when you said,

WPI is not any kind of standards agency.

BUT they are working hand-in-glove with folks who are like a de-facto standards agency. To whit, Holmberg's XMRV SWAT Team (one of many citations of the HHS Blood XMRV Scientific Research Working Group, this one at http://www.topix.com/forum/city/norcross-ga/TS8HRJ3SHJS08BKEN ) :

"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. (BINGO!) 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."(BINGO AGAIN!)
​

Am I off my rocker? Will I be wearing egg on my face? I hope not, but that's the least of my worries (and it would, admittedly be a rather humorous interlude). Consider my competing interests below...

Competing interests declared: 11 years of this bull is enough! There's more to life than writing! I wanna be a jock again! I wanna get well!:Retro wink:

So... any takers for my friendly egg-on-face wager?

 

[cfs since 1998]

I'm sorry but I don't see how there's a conflict of interest. If the VIP lab was a nonprofit organization giving its money to and being controlled by a for-profit company, that would be, but that is the precise opposite of the situation in question. In addition, is states clearly that the test license is non exclusive, which means any lab could purchase a license and conduct the same test.

 

[wornout]

Not sure if this is the right place to post this but does anyone have info on this lab offering XMRV Testing Clongen lab

http://clongen.com/XMRV_PCR_Testing.php

 

[consuegra]

It is my understanding that the antibody test will be available from VIPdx in mid-February. When and if the antibody test is available I am going to send another sample. VIPdx neglected to tell some patients to stay off antivirals for two weeks prior to the blood draw.

Chris

http://cfspatientadvocate.blogspot.com

 

[MEKoan]

Ok, maybe it's just because Parvo and I are both Canadians - an optimistic people, perhaps - but what Parvo says makes a whole lot of sense. I'm not sold on the multiple labs angle but maybe if I had a little poutine, I could see that, too.

I have been thinking that the most likely motivation to hurry a Weasely study would be to cover the tushies of anyone who has been denying patients medical services by "proving" that there is no XMRV in England :innocent1:

I can see no other rational explanation for running with scissors!

What am I saying! "Rational"? Silly me!

 

[George]

Sorry Worn out

Not sure if this is the right place to post this but does anyone have info on this lab offering XMRV Testing Clongen lab

http://clongen.com/XMRV_PCR_Testing.php

I googled em and came up empty. I thought I'd try some of the names next. (just got through licking my plate er. . . having dinner) They came out of the blue.

A valid test would explain some of the confidence and the fact that they are kicking up the commercial aspects of this really fast. I didn't expect to see this kinda of thing till middle of March maybe later.

It's pure speculation of course and we will just have to wait and see. However, we do know that HHS blood group has been working to create a bonifide "valid" test for screening the blood bank. A culture test could work for now. (hmmmm) We also know that the HHS has been doing a bit of quite maneuvering. The creation of the task force and moving the CFS department out of Women's health were done with no press releases, very much on the QT.

I figured that the HHS would want all of the blood screened and a simple test available before they would be comfortable with any publicity. Can they have achieved that so quickly??