XMRV in todays WSJ

[Guest guest]

http://blogs.wsj.com/health/2010/12/17/xmrv-still-waiting-for-a-test/

By Amy Dockser Marcus

Earlier this week, an FDA advisory panel recommended that the agency bar people

who report a diagnosis of chronic fatigue syndrome from donating blood amid

concerns about a possible link with the virus XMRV.

But reliably testing potential blood donors or people with CFS for XMRV isn’t

yet possible.

That’s the conclusion from the latest phase of an ongoing study launched by

the

HHS Blood XMRV Scientific Working Group, which was set up last year after a

paper in Science linked XMRV to CFS. An update on the study was presented to the

FDA advisory panel and again today on a webinar sponsored by the CFIDS

Association of America, a patient advocacy group.

Many groups are racing to develop an XMRV test in case it turns out that

potential blood donors need to be screened for XMRV. But in a presentation on

today’s webinar by Graham of Blood Systems Research Institute, the lab

that has been coordinating the working group studies, one of the slides summed

it up: Participating Labs — Discordant Results.

The first phase of the study evaluated the performance of XMRV tests developed

by a number of labs, including the Whittemore- Institute (which first

found the XMRV link to CFS), the CDC, FDA, and National Cancer Institute, among

others. All the tests did very well when looking for XMRV in blood samples that

had been spiked with it.

But in the second phase of the study, which had a subset of the labs look at

clinical blood samples from four people who tested positive for XMRV in the

Science study, things didn’t go as smoothly. In round one of this second

phase,

the CDC and the WPI labs were able to find XMRV in the plasma of at least some

of the patients. The NCI lab did not find any positives, despite having a very

sensitive test. So, they decided to do it all over again in the hopes of

confirming the findings. “Instead it went in the opposite direction,â€

Busch, director of Blood Systems Research Institute, tells the Health Blog.

When the same four people gave blood again, the three participating labs —

plus

a fourth commercial one — didn’t find XMRV in any of the plasma samples.

Some of the possible reasons why were discussed on the webinar. The number of

people involved was tiny, and it turns out that one of the four actually does

not have a CFS diagnosis but was a family member of someone with CFS. Another

one of the four started taking anti-retroviral medication around the time her

blood was drawn, which also could have impacted the results. Or, it’s possible

that the amount of virus present varies over time and was low when these samples

were taken.

So what’s next? Phase 3, which is going to include much larger numbers of CFS

patients (30) and even larger numbers of healthy controls (40-50), say the

working group scientists. More commercial labs are likely to be brought in to do

testing. Blood will likely be drawn in January, with results in possibly three

months later. “It is a frustrating process,†Busch says, “but we are

staying

the course and moving to Phase 3.â€

[Guest guest]

Bill, These developments are very interesting & it took them 10 or so years from

the date when some folks started talking about it.

This is all about CFS but is there much being talked about in the context of

Immune Dysfunction in children leading to Autistic symptoms & delays etc. or is

that still a minority & are we looking at another 10 years. How can parents who

are impacted help?

Thanks,

Kay

________________________________

From: Bill klimas <klimas_bill@...>

Cc: neuroimmune-xmrv-alliance

Sent: Sun, December 19, 2010 5:44:42 AM

Subject: XMRV in todays WSJ

http://blogs.wsj.com/health/2010/12/17/xmrv-still-waiting-for-a-test/

By Amy Dockser Marcus

Earlier this week, an FDA advisory panel recommended that the agency bar people

who report a diagnosis of chronic fatigue syndrome from donating blood amid

concerns about a possible link with the virus XMRV.

But reliably testing potential blood donors or people with CFS for XMRV isn’t

yet possible.

That’s the conclusion from the latest phase of an ongoing study launched by

the

HHS Blood XMRV Scientific Working Group, which was set up last year after a

paper in Science linked XMRV to CFS. An update on the study was presented to the

FDA advisory panel and again today on a webinar sponsored by the CFIDS

Association of America, a patient advocacy group.

Many groups are racing to develop an XMRV test in case it turns out that

potential blood donors need to be screened for XMRV. But in a presentation on

today’s webinar by Graham of Blood Systems Research Institute, the lab

that has been coordinating the working group studies, one of the slides summed

it up: Participating Labs — Discordant Results.

The first phase of the study evaluated the performance of XMRV tests developed

by a number of labs, including the Whittemore- Institute (which first

found the XMRV link to CFS), the CDC, FDA, and National Cancer Institute, among

others. All the tests did very well when looking for XMRV in blood samples that

had been spiked with it.

But in the second phase of the study, which had a subset of the labs look at

clinical blood samples from four people who tested positive for XMRV in the

Science study, things didn’t go as smoothly. In round one of this second

phase,

the CDC and the WPI labs were able to find XMRV in the plasma of at least some

of the patients. The NCI lab did not find any positives, despite having a very

sensitive test. So, they decided to do it all over again in the hopes of

confirming the findings. “Instead it went in the opposite direction,â€

Busch, director of Blood Systems Research Institute, tells the Health Blog.

When the same four people gave blood again, the three participating labs —

plus

a fourth commercial one — didn’t find XMRV in any of the plasma samples.

Some of the possible reasons why were discussed on the webinar. The number of

people involved was tiny, and it turns out that one of the four actually does

not have a CFS diagnosis but was a family member of someone with CFS. Another

one of the four started taking anti-retroviral medication around the time her

blood was drawn, which also could have impacted the results. Or, it’s possible

that the amount of virus present varies over time and was low when these samples

were taken.

So what’s next? Phase 3, which is going to include much larger numbers of CFS

patients (30) and even larger numbers of healthy controls (40-50), say the

working group scientists. More commercial labs are likely to be brought in to do

testing. Blood will likely be drawn in January, with results in possibly three

months later. “It is a frustrating process,†Busch says, “but we are

staying

the course and moving to Phase 3.â€