Fibromyalgia Immune Blood Test Going Mainstream?

The FM/a Fibromyalgia Blood Test

  • I have FM, I tried the test and I was positive

    Votes: 1 2.0%
  • I have FM, I tried the test and was negative

    Votes: 0 0.0%
  • I have FM, I tried to get the test done but my doctor wouldn't go for it

    Votes: 2 4.0%
  • I have FM, I tried to get the test done but my insurer wouldn't go for it

    Votes: 1 2.0%
  • I have FM, I haven't tried the test but would like to

    Votes: 29 58.0%
  • I have FM and I'm not interested in taking the test at this time

    Votes: 2 4.0%
  • I have ME/CFS, I tried the test and I was positive

    Votes: 1 2.0%
  • I have ME/CFS, I tried the test and was negative

    Votes: 0 0.0%
  • I have ME/CFS, and I would like to try the test

    Votes: 32 64.0%
  • I have ME/CFS, and I'm not interested at this time.

    Votes: 0 0.0%

  • Total voters
    50

Cort

Founder of Health Rising and Phoenix Rising
Staff member
Everytime this comes up I get so excited. Then I stop and think about what it would mean if the test is faulty. I don't know if it's a typo," it's correct 95% of the time), with a specificity (false positive rate) of about 95%." this doesn't make sense unless I'm missing something. Correct 95% of the time and a false positive rat of 95%. Cort, can you explain this please?
I've been sick for so long I don't even know what normal feels like anymore. In addition, I really have a strong feeling that Fibromyalgia is a disease of the nervous system. The one doctor, Neurologist, that I spoke to I really trust. He told me that the nervous system becomes unorganized and things that shouldn't be painful, become painful. Like clothing, bedding, and just about everything else. I will say that the most difficult part of Fibromyalgia for me is always having that horrible flu like feeling. The deep aches, the foggy head, the tingling skin. The inability to shower, wash my hair, do my laundry.
I have a host of pain that isn't fibromyalgia related. I have several autoimmune diseases and the worst is a tendon disordere.
So a test of the immune system. Yeah, doesn't make sense to me.
I redid that sentence. I meant to say that it misdiagnoses people with FM only 5% of the time....I think that's what specificity refers to...I think...:)

Gillis said he looked at fibromyalgia and he said what in the body could cause so many different symptoms and the answer he got was....the immune system...
 

Remy

Administrator
specificity (false positive rate) of about 95%." this doesn't make sense unless I'm missing something. Correct 95% of the time and a false positive rat of 95%. Cort, can you explain this please?
A test with high specificity has few false positives...in other words, a test with high specificity will rarely give a false positive result.

Specificity is not the rate of false positives, it's the rate of true negatives.
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
A test with high specificity has few false positives...in other words, a test with high specificity will rarely give a false positive result.

Specificity is not the rate of false positives, it's the rate of true negatives.
Thanks ;)
 

LisaR

Member
I wonder if the set of symptoms we call Fibromyalgia is caused by immune system problems in some people and CNS problems in others? For some people, it seems the trigger was Lyme disease or a virus. For me, the trigger was definitely more nervous system related-- a year of unrelenting stress and grief while caring for a mentally ill sister who eventually committed suicide, a son who dropped out of college, a flood that damaged our house. On the other hand, I don't feel like I have immune system problems. I rarely get sick and my blood work doesn't show any inflammation.
I'm almost afraid to take a blood test like this. If my Fibromyalgia is more nervous-system related than immune-system, would this test come back normal? And would that then call into question my diagnosis of FM?
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
I wonder if the set of symptoms we call Fibromyalgia is caused by immune system problems in some people and CNS problems in others? For some people, it seems the trigger was Lyme disease or a virus. For me, the trigger was definitely more nervous system related-- a year of unrelenting stress and grief while caring for a mentally ill sister who eventually committed suicide, a son who dropped out of college, a flood that damaged our house. On the other hand, I don't feel like I have immune system problems. I rarely get sick and my blood work doesn't show any inflammation.

I'm almost afraid to take a blood test like this. If my Fibromyalgia is more nervous-system related than immune-system, would this test come back normal? And would that then call into question my diagnosis of FM?

That's a great question...I think our knowledge of FM and ME/CFS is very limited and there are likely to be quite a few subsets. I don't think anyone could legitimately say one way or the other regarding FM or ME/CFS based on the results of one test. That said, immune problems can cause a heck of a lot of symptoms and most of the inflammatory markers tested for are pretty crude and don't tell the whole story apparently.
 

Victor Maalouf

Active Member
This whole thing is very complex. It seems that those of us also dx with FM may have 'different' immune systems. How many of us remember allergies, hives for most of our lives? Ten months after my spinal injury I had the typical butterfly lupus face rash. I did not go on to get dx with lupus. I think it is important for the interaction between the nervous system and immune system to be better understood.
That's interesting. I've seen many with Lupus who have clear mechanical issues, but didn't want to go too much into Lupus being musculoskeletally rooted because its signs and Dx are more established.

Just did a quick YouTube search and found one woman with extremely clear clavicular dislocation, and another video of 5 women with clear shoulder/clavicle/facial asymmetry.

I am wary of this blood test diagnosis for FM or even CFS/ME. On one hand it may be nice for there to be a definitive diagnostic test, depending on how accurate it actually is, so that patients' problems can be recognized and taken seriously by doctors and covered by insurance.

But on the other hand, it could entrench FM within the established heavily-drugged medical system. If this blood test is accepted and it makes doctors and researchers think FM is a nervous or immune system disorder at its root, then they're just going to research and throw drugs at it, and you can wave real treatment progress goodbye for another few decades. The test itself is almost $800. That's about 8 physical therapy treatments.


When the whole "small fiber neuropathy" thing came out I just saw it as another distraction that no one will ever understand. Even if a drug was created to cure the central widespread pain aspect of Fibromyalgia, you're still going to have musculoskeletal issues that will continue to cause pain. They're not going to just disappear.

I mean, doesn't this piss you off? The uselessness of the string of doctors I saw while crashing sure as hell pissed me off. When I noticed how bad my mechanical dysfunction had gotten, I immediately decided to start there. Because regardless of whatever else was wrong with me, why I had super fatigue, brain fog, MCS, IBS, weird pain, etc, my mechanical issues were something that needed to be addressed. When I did, I was pleasantly surprised (but not really) to find the other problems started to melt away.

In conclusion, the medical system is way too reliant on blood tests. It should not be encouraged. All of these problems really may not be as complicated as people think.
 

Katherine Autry

Active Member
I wonder why there is a disconnect between your CRP and your IL-6 levels? I'm only asking these questions in order to validate the IL-6 readings. The Haptoglobin test is another external validation marker.

The disconnect is very very interesting.

Thank you for replying

I wonder how the study finding the IL-6 readings was structured - did it choose patients who had been ill for several years or decades or limit it to patients that had just begun to show symptoms? Was it severely ill patients only or anyone with a diagnosis? What diagnostic criteria were used or did it include patients diagnosed at different times with different criteria such as we know happens with CFS? We also know that CFS test results differ between those within 3 years of onset and those with long term/late stage disease. It seems to be that the disconnect described is something to explore with further research to actually find the key to the problem, rather than just to validate or invalidate the IL-6 findings. In other words, lets not assume that this disconnect can only invalidate the findings, let's assume that if there is an impossible disconnect, we have more to learn.
 

Merida

Well-Known Member
That's interesting. I've seen many with Lupus who have clear mechanical issues, but didn't want to go too much into Lupus being musculoskeletally rooted because its signs and Dx are more established.

Just did a quick YouTube search and found one woman with extremely clear clavicular dislocation, and another video of 5 women with clear shoulder/clavicle/facial asymmetry.

I am wary of this blood test diagnosis for FM or even CFS/ME. On one hand it may be nice for there to be a definitive diagnostic test, depending on how accurate it actually is, so that patients' problems can be recognized and taken seriously by doctors and covered by insurance.

But on the other hand, it could entrench FM within the established heavily-drugged medical system. If this blood test is accepted and it makes doctors and researchers think FM is a nervous or immune system disorder at its root, then they're just going to research and throw drugs at it, and you can wave real treatment progress goodbye for another few decades. The test itself is almost $800. That's about 8 physical therapy treatments.


When the whole "small fiber neuropathy" thing came out I just saw it as another distraction that no one will ever understand. Even if a drug was created to cure the central widespread pain aspect of Fibromyalgia, you're still going to have musculoskeletal issues that will continue to cause pain. They're not going to just disappear.

I mean, doesn't this piss you off? The uselessness of the string of doctors I saw while crashing sure as hell pissed me off. When I noticed how bad my mechanical dysfunction had gotten, I immediately decided to start there. Because regardless of whatever else was wrong with me, why I had super fatigue, brain fog, MCS, IBS, weird pain, etc, my mechanical issues were something that needed to be addressed. When I did, I was pleasantly surprised (but not really) to find the other problems started to melt away.

In conclusion, the medical system is way too reliant on blood tests. It should not be encouraged. All of these problems really may not be as complicated as people think.

@Victor Maalouf
I am with you Victor. Thanks for the videos. I think you are right. I do not think we will be able to understand these disorders with out understanding the structural foundation. I certainly would be happy if offending viruses could be identified and treated . As you know, my son had severe Epstein- Barr at age 5/1986. But, he went on to develop scoliosis and the associated body asymmetries you discuss. And, he had some birth trauma.

I expect that musculoskeletal structural issues are causing stresses in the function of the CNS, dysfunction of the blood-brain barrier , allowing viruses easier entry to the CNS. I sound like a broken record. But, wouldn't it be great to get some research on this.
 

Merida

Well-Known Member
One more thing: Over a period of 18 years I have had various immune abnormalities - interleukins, elevated C reactive protein, elevated tumor necrosis factor alpha. But, these fluctuate and are not consistent. So ?????
 

KweenPita

Active Member
FMS isn't my only DX. I don't feel it is the complete "cause" of those of us with such complexities. It's one piece of the puzzle. For me, my inflammation markers shot up really high with a mold exposure. It caused all sorts of inflammation. I also have MCAS, and it seems to be associated with inflammation. Along with Lyme and other protozoa. If the immune system were working properly, NONE of these things would be a problem. The body would adjust accordingly instead of faulty reactions of either over reacting or not detecting at all. So bottom line - immune system dysfunction and inflammation. Probably in that order.
Issie
Thank you that helps and explains a lot, since I got disability for Fibromyalgia and diagnosed with Fibromyalgia 3 times without markers for MS, LUPUS and CFS, my Doctors are just happy to let it lie. But my immunological system is shot, and until I got Fifth's Disease, Human Parvovirus B19, and then Cervical Cancer caused by an agressive HPV, though we had been monogamous for 12 years, I had been never been one to ever get sick, no virus bugs, no sore throats, nothing. After, I became more and more susceptible, till I couldn't even fight off the staph infection. So it makes since, more is going on. I am trying to raise my PH levels on my own because in theory my body will become a hostile environment for bugs, even if my immunological system is weak. My one hope here in Atlanta is to be sent to the University of Alabama Hospital Fibromyalgia Clinic, which is supposed be cutting edge, but for that I need to get one of my Doctors to recommend me and hear me, not just put me on a shelf as maintenance as best can
 

KME

Member
Great to see the immune system getting more attention in fibromyalgia research. Seems to have been woefully understudied. I understand people wanting to have the blood test, but I would be concerned about the potential for harm if a genuine patient tests negative. It would be very unusual if this blood test really was as accurate/sensitive/specific as is being claimed! Rarely so straightforward in other diseases. I’d like to see their findings replicated in a large multi-centre study, ideally internationally.

Interesting that an Australian group from Griffith University have reportedly come up with a blood test for chronic fatigue syndrome http://mpegmedia.abc.net.au/news/audio/pm/201602/20160229-pm07-fatiguediscovery.mp3 although they say it won't be available for a few years. It doesn't sound like they're measuring the same thing as this fibromyalgia test, though.

I saw the quote in Cort's post where the FM/a test makers say chronic fatigue syndrome (their term) is just another name for FM and see this is reiterated in their paper http://bmcclinpathol.biomedcentral.com/articles/10.1186/1472-6890-12-25. It would be interesting to see how people with diagnoses of ME/CFS, FM, ME/CFS + FM fare on both tests! I’d say there’ll be a good bit of reshuffling/rediagnosing/recategorising as time goes on.

It will be interesting to see how all of this pans out over the next few years.
 

madie

Well-Known Member
My doctor OK'd this test for me! In fact he's pretty excited about it. I should get it on Saturday and do the blood draw on Monday. Then it's 7 working days to results, which are mailed to the doctor.
 

jewelll

New Member
Holy Grail

A blood test is like the holy grail for contested diseases like fibromyalgia or chronic fatigue syndrome (ME/CFS). Doctors understand and believe in blood tests. An abnormal blood test means something physiologically has gone wrong - end of discussion.

[fright]View attachment 1309 [/fright]A blood test has never been out of the realm of possibility in FM, and a California company called Epigenetics, believes it has one. The shocker? It's an immune test for this putative central nervous system disorder.



The first hint of a blood test for fibromyalgia came in 2012 when researchers found not just small or moderate but large reductions in the immune response in FM patients. Depending on the type of immune challenge used (PHA, PHM) FM patients responded from 1.5 to 10 times less robustly than healthy controls.

It was a good start in a disease that few have associated with immune issues but the best was yet to come. They followed that study up with a 500 person study in 2015 contrasting immune biomarkers in FM, rheumatoid arthritis and lupus. They compared scores for an algorithm developed around four possible immune markers (interleukin-6, interleukin-8, macrophage inflammatory protein-1 alpha and macrophage inflammatory protein-beta (IL-6, IL-8, MIP-1a and MIP-1b) produced in response to mitogenic stimulation.

Theywere able to identify 89% of the healthy controls and 93% of the fibromyalgia patients successfully. The test wasn't as effective with the RA and SLE patients, however. It successfully identified 69% of the RA patients and 71% of the SLE patients. That's important because lupus and RA can masquerade as FM and misdiagnoses are common..

The authors believed, however, that the medications the FM and SLE patients were taking accounted for the lower specificity seen; i.e. the test would be more accurate in new patients. (Most of the autoimmune patients in the study were on medications.)

[fleft]View attachment 1308 [/fleft]An astonishing drop in IL-6 levels (p<.00001 ) in the FM patients relative to the other rheumatological diseases and healthy controls really set FM patients apart. It appears that this cytokine - which plays a major role in the innate or early immune response - plays a major role in the disease. The good news is that IL-6, which also implicated in stress, fatigue, hyperalgesia and sympathetic nervous system activation, fits what we know about FM and ME/CFS.

The authors believe that central sensitization disorders such as FM are characterized by blunted responses in three major systems; the immune, autonomic nervous system and hormonal responses. It bears noting that blunted parasympathetic and HPA axis findings are characteristic of both ME/CFS and FM.

There were some problems with this study, and the authors called it's findings "preliminary". Although it's known that cytokine levels change during the day, the samples weren't taken at a specific time. FM patients with RA or SLE weren't filtered out of the study, and RA and SLE patients were taking drugs that might have interfered with the results. Correcting these issues, it should be noted, would likely strengthen not dilute the next study results.

Two big studies - not perfect studies by any means - but very large studies, then have had consistent results. It helps that these findings pretty much mirror what we're learning about FM and ME/CFS; that these are, at least in their later stages, more immune depletion than immune activation diseases.

A Conversation Changer?

Dr. Gillis oozed confidence in a 2013 interview. This test (called FM/a) was going to make believers, he predicted, of the 90% of the doctors who still don't believe FM is a real disease. That's a pretty incredible percentage given all the brain imaging studies that have been done in FM bu there is something about the blood that's different. A blood test, if it really got around, just might do it.

Epigenetics, the manufacturer of the test, believes similarly. It states:



The test, Dr. Gillis claimed, is now as sensitive as the HIV test (it's correct 95% of the time), with a specificity (doesn't misdiagnose incorrectly) of about 95%.

Insurance Companies Sign On

[fright]View attachment 1310 [/fright]It may take a while to get to those doctors, but a recent report suggests that Gillis is making believers of the insurance companies. The National Pain Report recently reported that most Medicare plans are now paying for the expensive ($749) test, and major private insurers such as UnitedHealthcare, Blue Cross Blue Shield and Aetna are paying for the test on a case by case basis.

Why would they start covering such an expensive test? Because FM patients often go through tens of thousands of dollars of (negative) testing before they finally get diagnosed That means the insurance companies bottom line is positively effected if they can get FM patients diagnosed as quickly as possible.

Getting Tested

Epigenetics, the producer of the test, is trying to get as many FM patients as it can tested. They have a quiz (do you suffer from chronic pain - or ME/CFS patients note - chronic fatigue, brain fog, unrefreshing sleep, anxiety, etc. ) which suggests suitability. Then they provide a patient information form. They will then contact the patients insurer to see if they will cover the test.)

Why, if you've already been diagnosed with FM, would you want to get tested? I would argue that it's good for the field and good for the doctors in the field to see this test, if it does work. work. Your doctor may also think a bit differently about FM pre and post test results.

With the small fiber neuropathy findings, Dr. Pridgen's antiviral protocol and the FM/a immune test, it's definitely interesting times for the immune system and FM.

Health Rising is not affiliated with Epigenetics
I would argue that the insurance companies are hoping that the blood test will not work and come up negative and they can deny you insurance and if positive can create problems with life insurance. I have been diagnosed a long time ago and no way will I take this blood test as am on disabiltiy insurance at this time.
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
Great to see the immune system getting more attention in fibromyalgia research. Seems to have been woefully understudied. I understand people wanting to have the blood test, but I would be concerned about the potential for harm if a genuine patient tests negative. It would be very unusual if this blood test really was as accurate/sensitive/specific as is being claimed! Rarely so straightforward in other diseases. I’d like to see their findings replicated in a large multi-centre study, ideally internationally.

Interesting that an Australian group from Griffith University have reportedly come up with a blood test for chronic fatigue syndrome http://mpegmedia.abc.net.au/news/audio/pm/201602/20160229-pm07-fatiguediscovery.mp3 although they say it won't be available for a few years. It doesn't sound like they're measuring the same thing as this fibromyalgia test, though.

I saw the quote in Cort's post where the FM/a test makers say chronic fatigue syndrome (their term) is just another name for FM and see this is reiterated in their paper http://bmcclinpathol.biomedcentral.com/articles/10.1186/1472-6890-12-25. It would be interesting to see how people with diagnoses of ME/CFS, FM, ME/CFS + FM fare on both tests! I’d say there’ll be a good bit of reshuffling/rediagnosing/recategorising as time goes on.

It will be interesting to see how all of this pans out over the next few years.
I tried to find out what they were measuring and I didn't get an answer back from my email :(
 

Issie

Well-Known Member
Thank you that helps and explains a lot, since I got disability for Fibromyalgia and diagnosed with Fibromyalgia 3 times without markers for MS, LUPUS and CFS, my Doctors are just happy to let it lie. But my immunological system is shot, and until I got Fifth's Disease, Human Parvovirus B19, and then Cervical Cancer caused by an agressive HPV, though we had been monogamous for 12 years, I had been never been one to ever get sick, no virus bugs, no sore throats, nothing. After, I became more and more susceptible, till I couldn't even fight off the staph infection. So it makes since, more is going on. I am trying to raise my PH levels on my own because in theory my body will become a hostile environment for bugs, even if my immunological system is weak. My one hope here in Atlanta is to be sent to the University of Alabama Hospital Fibromyalgia Clinic, which is supposed be cutting edge, but for that I need to get one of my Doctors to recommend me and hear me, not just put me on a shelf as maintenance as best can
You being in Atlanta, maybe check to see if mold could be an issue.
 

madie

Well-Known Member
My doctor just emailed me that this test was positive. I should get a copy of the results in the morning.

I never thought I had fibromyalgia because the diagnostic trigger points don't bother me. Now I see that they aren't used for diagnosis any more. The rest of the symptom picture fits me perfectly; I'm only missing the mood disorder part.

After 30 years of having CFS, maybe I don't have it. This feels very weird.
 

Remy

Administrator
My doctor just emailed me that this test was positive. I should get a copy of the results in the morning.

I never thought I had fibromyalgia because the diagnostic trigger points don't bother me. Now I see that they aren't used for diagnosis any more. The rest of the symptom picture fits me perfectly; I'm only missing the mood disorder part.

After 30 years of having CFS, maybe I don't have it. This feels very weird.
Unfortunately, you can have both. :(

But it's always good news to find things that may influence your treatment strategy and lead to a better quality of life overall! I hope that is what happens...
 

Empty

Well-Known Member
My doctor just emailed me that this test was positive. I should get a copy of the results in the morning.

I never thought I had fibromyalgia because the diagnostic trigger points don't bother me. Now I see that they aren't used for diagnosis any more. The rest of the symptom picture fits me perfectly; I'm only missing the mood disorder part.

After 30 years of having CFS, maybe I don't have it. This feels very weird.

@madie what is this test? Is it available in uk? Thanks.
 

madie

Well-Known Member
I took a screen shot of the results, but can't figure out how to copy that here. The results are very disappointing. All you get is a number (1-100), which is your result, on a graph. If your number is below 50 you are "not confirmable." 50-80 is "confirmable." 81-90 is "strongly confirmable," and 91-100 is "extremely confirmable." I'm 55, so what's that? Just barely confirmed? Confirmed with extreme prejudice?

There are is no other information, which means I can't use this result for anything but insurance reimbursement. It looks like it was developed to differentiate FM people from those with Lupus and RA. Maybe that's why they can get away with not giving me actual test results.

@Empty https://thefibromyalgiatest.com/ You have to get blood drawn somewhere local to you, and an overnight shipping bag is provided. I doubt this is available outside the US.
 

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