Fibromyalgia Immune Blood Test Going Mainstream?

Discussion in 'ME/CFS and FM News' started by Cort, Apr 14, 2016.


The FM/a Fibromyalgia Blood Test

  1. I have FM, I tried the test and I was positive

    1 vote(s)
  2. I have FM, I tried the test and was negative

    0 vote(s)
  3. I have FM, I tried to get the test done but my doctor wouldn't go for it

    2 vote(s)
  4. I have FM, I tried to get the test done but my insurer wouldn't go for it

    1 vote(s)
  5. I have FM, I haven't tried the test but would like to

    28 vote(s)
  6. I have FM and I'm not interested in taking the test at this time

    2 vote(s)
  7. I have ME/CFS, I tried the test and I was positive

    1 vote(s)
  8. I have ME/CFS, I tried the test and was negative

    0 vote(s)
  9. I have ME/CFS, and I would like to try the test

    31 vote(s)
  10. I have ME/CFS, and I'm not interested at this time.

    0 vote(s)
Multiple votes are allowed.
  1. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff 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.

    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.)

    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

    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
    Last edited: Apr 19, 2016
  2. Issie

    Issie Well-Known Member

    Cool! When I was DXd with FMS at Mayo, I had two doctors trying to convince me it was a real DX. I felt like it was a label for something either unknown or not yet diagnosed. Having autoimmune issues and inflammation, I wasn't wrong. Still comes down to the bottom line - autoimmune and inflammation. Nice to have a way to measure it.

  3. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    The immune system keeps showing up.

    Isn't that something - I'll bet you're not alone...I wonder how many people who got diagnosed with FM or ME/CFS said - give me a real diagnosis!
    Patty May likes this.
  4. JennyJenny

    JennyJenny Well-Known Member

    Can't wait. My insurance company would not pay for it. Now they are saying Medicare will and I have BCBS supplemental for Medicare so maybe this year my doctor can order it.

    You still have to have this lab do the test and all you have to do is pay for the blood draw which they told me it is $25-$35 and they send it to this lab.
  5. Remy

    Remy Administrator

    Great timing, @Cort! I have an appt with my dr tomorrow and I'll get her to sign the form and report back.

    So if I have this right, IL-6 drops in both FM and CFS according to this research? My IL-6 has always been off the charts high and I'm well past 5 years sick now.

    My theory is that the mast cell activation is causing the high maybe we will find that a large subgroup of us are actually mast cell patients rather than the FM cohort. It would be cool if that could be used as a tool for differential diagnosis someday.
    Patty May and San Diego like this.
  6. Joanna

    Joanna Member

    Being in the UK and having to use the NHS, as I am living on government benefits, this costly test is completely out of my reach, even if I could convince a GP to order it. I do not know if it is available here. It would be interesting to know, even though most of us in the UK who are severely affected like me would not be able to do it. The NHS is too strapped for funds to pay for something like this. They provide us with pain medications and not much else.

    Does anybody have information about what the future holds for Fibromyalgia and ME patients in the UK needing something like this to prove that we have a real biomedical illness?
    UK Margaret likes this.
  7. What I would love to hear from you is: if your IL-6 levels are so high, do you also have elevated CRP and Haptoglobin levels, both of which are raised as a consequence of IL-6?

    Also, do you know if obesity is somehow connected to CRP elevations?

    John L Whiting
  8. Remy

    Remy Administrator

    I do not have an elevated hs-CRP. Last week it was 0.7 which is actually the highest it's ever been. My doctor said some type of inflammation don't raise hs-CRP and that was as far as it went when I asked that same question about IL-6 and hs-CRP.

    I've never tested haptoglobin or even heard of it, honestly. It's on the LabCorp test menu so if you can tell me a rationale for why I should test it, I'll order it with my next draw. :)

    I do think obesity is connected to hs-CRP elevations but I can't say how exactly. Since mine has never been high, I haven't studied it in any depth.
  9. KweenPita

    KweenPita Active Member

    I have been diagnosed since 1993, I presented more MS like symptoms but when symptoms became "full blown" in 9/91, I was just returning back to work for the school year after having a restful summer of pool and lounging. I was nine months out from recovery from.Cervical Cancer and a short round of Chemo.

    After two years of testing, and every time, I have had a , major health crisis that doesn't exactly fit Fibromyalgia and been retested for everything under the sun, I only test positive for high inflammation in my body of unknown origin. Everyone who hears this but you tells me, "It can't be Fibromyalgia then because Fibromyalgia isn't an inflammation disease".

    I have to admit y symptoms are a mixed bags of nuts with Lupus rashes and kidney disease, CFS sore throats, swollen glands, and total just feel like crying fatigue with these flares which happen when I over exert myself and of course the original nerve pain, spasms, sleeplessness, tired feeling, weakness, migraines.

    Then add a Thyroid that always tested normal but got ate up with nodules and died. A pancreas that goes on the Fritz and decided I was malnourished at 190, gaining 2-3 pounds a week on a very controlled diet. Whacked hormonal imbalances, too much testosterone. Another bout of Cancer. Than everything goes shot to hell, yes really.

    But last September as a Hail.Mary effort used High Grade Cannabis Oil and nerve pain mostly left, spasms calmed, general feeling better. Immune system, IBS, Interstitial Cystitis, Fatigue, Sore Throat flares and Chronic Back Pain still here, but this is vast improvement.

    How can this be? Am I like you an Fibromyalgia person who actually has inflammation? Does our species exist? Do you have any of the mixed bag of nut symptoms? If I am not being too personal. I really think this whole sage started maybe from Human Parvovirus B19 I got my first spring semester, teaching Early Childhood Education. Just some thoughts.
    Last edited by a moderator: Apr 15, 2016
    Katie likes this.
  10. claudia

    claudia New Member

  11. claudia

    claudia New Member

    Any connection between Epigenetics and VIP Dx?
  12. 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
    Merida likes this.
  13. Martinigal

    Martinigal Active 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 disorder.

    So a test of the immune system. Yeah, doesn't make sense to me.
    Last edited by a moderator: Apr 15, 2016
    LisaR and Merida like this.
  14. Issie

    Issie Well-Known 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.
    Merida likes this.
  15. Remy

    Remy Administrator

    I wonder why too! It's been high on several cytokine panels I've done though so I don't think it's an error. It's on my list of "unanswerable questions" for the moment....

    Do you have any speculations on the disconnect perchance?
  16. Merida

    Merida Well-Known 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.
    Katie likes this.
  17. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Good luck! Please tell us how it goes. :)
  18. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    That is going to be interesting. Yes it appears that IL-6 drops - when stimulated by mitogenic antigens (whatever they are). I wonder if yours might drop under stimulation...maybe???o_O
  19. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    I don't know but I imagine that more studies would help. If a major medical organization would back this test I imagine that would go a long way.....I hope to contact the company at some point and see what's next for them.
  20. Cort

    Cort Founder of Health Rising and Phoenix Rising Staff Member

    Not that I know of.