Blood Products Advisory Committee Meeting Background Material

[Eric Johnson from I&I]

It was boring, mostly. I thought Dr Le Grice was impressive. Because of what he's choosing to focus on, and also because of his very deliberate attitude.

 

[alex3619]

Hi,

I don't recall reading that this was confirmed on actual patients. They might be able to find the usual XMRV, but can they find it in us? They were looking for standard nucleic acids, not modified by the immune system.

Bye
Alex

This is excellent news now they have no reason not to be able to detect XMRV in both patient and general population. This means that a meaningful study of the true numbers and the correlation with XMRV + with illness of any type can be accomplished in a matter of months. Like by December, o.k. o.k. this IS the gov'ment let's say early in the spring of 2011. (big grins)

P.S. thanks Shrews for posting this!

 

[muffin]

Thank you for going and sitting there and taking notes. Don't you just love Gaithersburg?

"The worst part of Dr. Hendrys presentation for me was after it was over. We are used to the lying, the manipulation and the sheer audacity to give false information as though they are facts. But, when asked by Dr. Hollinger if the PCR gag was the same as the Lombardi study, he said Yes. A bold faced lie. Its one thing to read about these moments, but its quite another to see the lying in person, not to mention the slight swagger of Dr. Hendry as he walked back to his seat." THIS MUST HAVE MADE YOU CRAZY. HOPE THIS GUY GETS A GOOD SMACK IN THE BUTT WHEN IT ALL COMES OUT. What the heck is with these peope?????

 

[George]

Hi,

I don't recall reading that this was confirmed on actual patients. They might be able to find the usual XMRV, but can they find it in us? They were looking for standard nucleic acids, not modified by the immune system.

Bye
Alex

You would be correct, they tested blood samples from patients provided by the WPI and spiked to differing degrees. Butttttt. . . they look to be in "validation" or pre- production mode based on the article from Medsacape.

"The HIV single copy that was developed at the NCI is regarded as the gold standard assay. We now believe that we have an equivalent assay for XMRV."

Dr. Le Grice and his team have also developed a cell line, dubbed the Derse cell line, which can detect XMRV in as little as 3 days.

He said that the XMRV assay that his lab has developed has been transferred to labs in Sweden, Australia, Vietnam, and South Africa to prove its utility. "Developing an assay is one thing, but transferring it to a laboratory where it can be reproduced is clearly important when we are talking about single copy assay. Contamination is a huge problem, and the ability to transfer these reagents is very important," he noted.

Dr. Le Grice added that the aim of the NCI is to make sure that the assays they have developed are as valid as possible. "Our goal is to develop a series of assays that we feel confident in and to test those head to head with other assays. I think that is really important at the moment. We should start with 6 assays in house, and if we have a problem, I think it is important to sit amongst ourselves and try to understand where those problems are before we disagree with anybody else's assay."

 

[Lynn]

"The HIV single copy that was developed at the NCI is regarded as the gold standard assay. We now believe that we have an equivalent assay for XMRV."

Dr. Le Grice and his team have also developed a cell line, dubbed the Derse cell line, which can detect XMRV in as little as 3 days.

I have the test kit from VIP dx and am waiting to get my blood drawn until they have the serology test available (in the next 10 days). I am now wondering if I should wait to get tested. Maybe a validated test is just around the corner. I am afraid that if I only have the VIP dx test my insurance won't cover ARV therapy. Will I just be throwing $250 down the drain in my efforts to validate my illness?

Lynn

 

[SOC]

I have the test kit from VIP dx and am waiting to get my blood drawn until they have the serology test available (in the next 10 days). I am now wondering if I should wait to get tested. Maybe a validated test is just around the corner. I am afraid that if I only have the VIP dx test my insurance won't cover ARV therapy. Will I just be throwing $250 down the drain in my efforts to validate my illness?

Lynn

I've got two VIPdx test kits coming. I'm wondering the same thing... should I wait?

 

[Sushi]

Me too! I called VIP yesterday and they said that they hoped to have the test available by the end of the week. My test kit should arrive any day.....

What do others think?

Sushi

 

[George]

Only 250$ for an XMRV test????

New thread anyone?????

 

[Rrrr]

george, where did this below quote come from???



"The HIV single copy that was developed at the NCI is regarded as the gold standard assay. We now believe that we have an equivalent assay for XMRV."

Dr. Le Grice and his team have also developed a cell line, dubbed the Derse cell line, which can detect XMRV in as little as 3 days.

He said that the XMRV assay that his lab has developed has been transferred to labs in Sweden, Australia, Vietnam, and South Africa to prove its utility. "Developing an assay is one thing, but transferring it to a laboratory where it can be reproduced is clearly important when we are talking about single copy assay. Contamination is a huge problem, and the ability to transfer these reagents is very important," he noted.

Dr. Le Grice added that the aim of the NCI is to make sure that the assays they have developed are as valid as possible. "Our goal is to develop a series of assays that we feel confident in and to test those head to head with other assays. I think that is really important at the moment. We should start with 6 assays in house, and if we have a problem, I think it is important to sit amongst ourselves and try to understand where those problems are before we disagree with anybody else's assay."

 

[Rrrr]

cdc

so the cdc still says they can not find xmrv? i read on another thread (where?) that they now can find it. but at this FDA meeting they only reported that they can not find it?

 

[guest]

He D (love your sig, so true, so true)
With a bonafid serology test, they will need to "verify" it. (big grins) Which sound like Le Grice has already started that process by sending to other labs to confirm. But with a serology test all they have to do is draw the blood and test it. They should get definitive positive and negatives. Testing 500 or 5000 or even 50,000 is just a matter of having the necessary lab facility and the people to staff it. With existing labs the "400" person patient study that was outlined by the Working Group could be finish in a matter of days.

Plus, seeing that 95% of this group of ill persons (say CFS/ME), and 14% of that ill group (say atypical MS) or 4% of this group (say "Otherwise Healthy) could be whipped out and correlated in a couple of months. You've got time to "design" the study, time to fight about who get's to put their name on the study, (grins) time to do the dang study, time for some dweeb to write up the dang study. Whew, then time for some Gov'ment official to pressure some publication to print the dang study.

So that will give good correlations about who's got what and how much but it still won't tell ya "scientifically" that XMRV actually Causes anything. (grins) got to have more studies for that. (wink)

I'm hoping so much that you are right with this.

 

[anciendaze]

so the cdc still says they can not find xmrv? i read on another thread (where?) that they now can find it. but at this FDA meeting they only reported that they can not find it?

Here's a possible interpretation. They found XMRV in about 1% of tissue samples from prostate cancers. This was reported at a conference months ago. It looks like this allows them to say: 1) yes, we know how to find XMRV; 2) no, it is not in the blood supply. Had they failed to find it anywhere, they would have lost credibility. In this case, it seems the test assay was improved just enough to satisfy policy objectives.

I doubt we are out of the woods w.r.t. testing. Evidence for hypermutation, to say nothing of possible recombination, means finding specific sequences may be considerably more difficult than anticipated. If, as I suspect, most sequences were mutated prior to collection, the role of activation and biological amplification could be more important than simply increasing the number of copies.

If activation caused the virus to insert new copies of its genes, these would not be immediately subject to mutation. Assume, for the moment, biological amplification goes through four generations. If the sequences were already present, you might see a change from a single copy to 16. In this case, chance alone would suggest finding some XMRV, not 0%. On the other hand, if all preexisting inserted sequences were mutated, you might see a difference between zero copies and 16.

This idea may well be wrong, but it fits published results pretty well.

 

[Megan]

I doubt we are out of the woods w.r.t. testing. Evidence for hypermutation, to say nothing of possible recombination, means finding specific sequences may be considerably more difficult than anticipated.

I have been wondering about this too. It will be interesting to see what the Alter paper says on the CFS patients, whether they have XMRV or other MLVs? From the press leak it sounded like he was saying that there are other MLV's involved. If this means other MLVs than XMRV, then we could be waiting a long time for the testing to be sorted out - we may all have different MLV's. That would mean lots of different tests.

 

[George]

Happy Note (well sort of)

I have been wondering about this too. It will be interesting to see what the Alter paper says on the CFS patients, whether they have XMRV or other MLVs? From the press leak it sounded like he was saying that there are other MLV's involved. If this means other MLVs than XMRV, then we could be waiting a long time for the testing to be sorted out - we may all have different MLV's. That would mean lots of different tests.

Hey ya guys
When I started researching MLV's back in January I noticed an interesting phenomena. Two seperate papers from 1984 and 1987 were "republished" both papers were on the 'clearance of MLV's from human and primate systems within 10 days. MLV's themselves have passed the test of 40 years of use and testing in humans as essentially harmless.

Fast forward to Dr. Sandra Ruscetti (and Frank and Dr. Coffin and Dr. Goff and many others) Who have been studying Xenotropic - MLV - retroviruses in "other" mammals for over 20 years. One of the main features that were found was that many of these species of MLV's "recombined" with other MLV's to get by the animals defenses. But a base MLV was observed in all cases. In other words SFFV might recombine with other MLV's but the SFFV was the base virus needed in order for the other MLV to recombine.

So test us for XMRV, if we have XMRV, treat for the XMRV retrovirus. The other MLV's will clear from the system. Course this is the simplest version, there's still secondary infections ,problems with IRIS, medication side effects and all that good stuff. But hey it will be a start.

 

[markmc20001]

CDC

Here's a possible interpretation. They found XMRV in about 1% of tissue samples from prostate cancers. This was reported at a conference months ago. It looks like this allows them to say: 1) yes, we know how to find XMRV; 2) no, it is not in the blood supply. Had they failed to find it anywhere, they would have lost credibility. In this case, it seems the test assay was improved just enough to satisfy policy objectives.

Am I understanding correctly that the CDC claims to have found XMRV in only 1% of prostate cancer tissues? Does that sound kind of like the CDC is giving the same XMRV denial treatment to prostate cancer folks?

if that is the case....yikes.