Finally, a blood test available for fibromyalgia!

BY Karen Lee Richards

from this site: http://www.healthcentral.com/chronic-pain/c/5949/159421/diagnostic-fibromyalgia/?ap=2007

Quite frankly, I wasn't sure I would ever have the opportunity to write about an actual laboratory test for fibromyalgia in my lifetime. But before I organize a parade to celebrate, I have a few questions that are as yet unanswered.

The test––called the FM/a® test––was developed by EpicGenetics, a privately-held biomedical company “dedicated to developing conclusive diagnostic medical tests for complex medical conditions where no definitive testing is available.” EpicGenetics calls it “the first test to objectively diagnose fibromyalgia via a simple blood test.”

How the FM/a® Test Works

According to the developers, “FM/a® is a multiple biomarker-based test, which measures protein molecules called cytokines within white blood cells, a key part of your immune system. People with significantly lower cytokine levels have fibromyalgia. It uses a 1-100 point scoring system to determine diagnosis, and it calculates a positive fibromyalgia diagnosis as a score between 50 and 100 points.”

They say that FM/a is more than 93% sensitive, a sensitivity comparable to the HIV blood test. By comparison the rheumatoid arthritis blood test is only 65% sensitive. No medical test is 100% accurate.

The FM Test – When, Where and How Much?

When: The new FM/a test will be available beginning March 4, 2013.

Where: You can order an FM/a Test Kit at thefmtest.com or by calling 855-775-FIBRO, however, the test is only available upon the order of a licensed physician. Visit The FM Test Website for instructions on what to do when you receive the test kit. They also have an option available for people who do not have a regular doctor.

How much: Here's the real drawback for most of us––this is not an inexpensive test. It costs $744, plus your doctor's office or laboratory may charge an additional fee for drawing the blood. And since it is a new test, it's unlikely that most insurance companies will cover it yet.

What do you think about this new diagnostic test for FM? Will you consider having the test done?

The Research Behind the Test

The FM/a test was developed as part of an 18-month long study comparing cytokine responses in 110 FM patients and 91 healthy controls. The research, published in BMC Clinical Pathology in December 2012, concluded, “The cytokine responses to mitogenic activators of peripheral blood mononuclear cells isolated from patients with FM were significantly lower than those of healthy individuals, implying that cell-mediated immunity is impaired in FM patients. This novel cytokine assay reveals unique and valuable immunologic traits, which, when combined with clinical patterns, can offer a diagnostic methodology in FM.”

One of the most interesting things I found in this study was a statement at the end of the authors' discussion. “In the past, FM was claimed to be a rheumatologic, neurologic or psychiatric disease despite the fact that there were no objective links to any of those pathways. Our findings uncovered evidence that FM is instead an immunologic disorder. They prove that the immunologic basis of FM occurs independently of any subjective features. Hence, this illustrates the very strong clinical value of our test protocol. The fact that individual cytokines exhibited similar dynamics in patient samples reveals that the FM patients are uniform in regard to their cellular immunologic responses.”

The full text of the journal article is available for free here: Unique immunologic patterns in fibromyalgia.

My Unanswered Questions

While this study is impressive and the results encouraging, I still have a few questions regarding the test:

  1. In the study, the test was only used to distinguish between FM patients and healthy controls. How would the test fare when trying to distinguish FM from other pain-related disorders?

  2. Patients with any rheumatologic, autoimmune, immunologic, inflammatory, infectious or neoplastic disorder were excluded from the study. Would the test identify FM if a patient has another illness as well?

  3. Study participants were not allowed to take any FDA-approved medications for FM, nor were they allowed to take anti-inflammatory or other medications that affect the immune system. Will patients be required to discontinue their medications before taking the FM test in order to get an accurate result?

Until these questions are answered, I'll remain cautiously optimistic.

It's exciting but I sure wish the price was significantly less! How many people with fibro could afford it? Maybe it'll become a standard test for fibro eventually. I have to admit, curiosity really does want to kill the cat here, as I'd love to take the test to see what's what.

Thanks for reposting this, Sheila. It really is an exciting new step in the diagnosis and eventual treatment of fibro.

Well Petunia and Eydis,

The next step is to get this passed by the insurance companies and the American Medical Association as a standard test. Then we will only pay our portion of the insurance. Then we can afford it. So just hang on a bit longer.

The test is not specific for Fibromyalgia, nor for any other medical condition. The authors of the study failed to disclose a conflict of interest. Dr Bruce Gillis, founder of EpicGenetics, has a commercial interest through his company, EpicGenetics. Professor Dan Wallace admits that the test might be useful in less than 1% of cases. More details are available on Fibromyalgia Perplex, the blog site of Professor Fred Wolfe. Look for Junk Science - Junk Ethics. I am not sure why Professor Wallace would want to be a member of the Scientific Advisory Board of said company. Particularly after they posted his photograph on their website without first seeking his permission. My advice? Caveat emptor (Let the buyer beware).

Thank you, Dr Quintner!

Would you be so kind as to give us your definition of fibromyalgia, I am curious if it is similar to the one given me by my Rheumatologist, who is also Asst Professor of the University West Virginia (lab studies) besides a practicing physician. There does not seem to be a great deal of agreement on the subject.

Dr. Quintner posted his response on my profile page:

http://www.livingwithfibro.org/profiles/comment/list?attachedToType=User&attachedTo=1v28qx22c744i&commentId=3965623%3AComment%3A173181&xg_source=activity

Hello Sheila,

Great discussion mate and very interesting and i really hope insurance companies will cover the cost of the test.

There's just one draw back for me it's a shame it's not purely a 100% test for fibro.:)

If they perfect the test, and it was available in Canada, I would get it. If only to wave the results under my rheumy's nose, haha! thanks for posting this, hugs Charlie.

Well the other problem with a test this new is that most doctors don't understand why the test proves you have fibromyalgia. So we will be waiting for this to be standardized, and for doctors to read about it so they know the reason it indicates fibromyalgia. If other doctors won't accept the test yet, it's useless. So we have to wait for it to get a medical code and to be put into mainstream medicine.

Sheila, sorry to disappoint you but in my opinion the test, as promoted, will never get a medical code and be part of mainstream medicine. It DOES NOT indicate Fibromyalgia Syndrome nor any other medical condition. Check out Junk Science - Junk Ethics on the blog run by Professor Fred Wolfe (Fibromyalgia Perplex).

John, you haven't disappointed me, because I think it's a great first step, and many better tests may come from the faults of a first test. Second or third generation fibro test will for sure be even better than the first. If you have a chance, can you please find the page you are speaking of, and copy the link address at the very top of the screen, and paste it here for other Fibro patients to see? Thanks on behalf of all of us.

John, thanks for your opinion. You certainly have a right to share your thoughts. I agree, buyer beware, even with medical tests and doctors and such. WE wrongly trust doctors to the point of thinking they can't make errors.

I'm no Dr, I speak from a layman's point of view. I don't think it's a conflict of interest for those who developed the test to get paid for taking the test. After all, it's that company that will be supplying the test solution (chemical) even when it goes mainstream. Every big pharma and every company that discovered a breakthrough test will get paid for their product. I've been reading about the presence of excessive cytokines in fibro patients for a long time, so this is not really a junk science test. One thing I think you will agree with though, is that many people who have been diagnosed with fibro were only diagnosed with it because a number of other tests came out negative. I have seen so many people who got more extensive testing by an endocrinologist or virologist, who were discovered to have a different disease, so the diagnosis was dropped. If only those who do not have a different ailment are the ones with high cytokines, the test would not be good, but if everyone who has the symptoms of fibro, despite the cause, do have low cytokines, the test would work well for a fibro diagnosis until further testing could prove something different. I think a large portion of Fibro patients could have a mitochondrial disorder that has not yet been discovered and they don't have access to a Dr. who could find the true cause of the muscle pain and internal symptoms. The problem is that most of us are treated by doctors who learned (wrongly) that Fibro is a complainer's disease, a waste-basket term, and the patients are to be avoided and not treated with the same respect as people with other diseases. It has only been in the past 5 years or so that the curriculum in medical schools has improved in regards to lupus.

Many of us have other diseases along with Fibro, so can we attribute our fibro symptoms to that other disease, or is Fibro a completely separate disease? And what makes it a separate disease? If it is low cytokines, we now have a test for it. Even if just one aspect of Fibro is low cytokines, this tests for that, and in the future, the test may detect many variations in Fibro patients.

In another place, you stated that there is no brain scan that will show fibro. I disagree there too. The SPECT scan shows blood proliferation, or lack of it, that are specific to Fibro patients. Here's an article about it.

http://www.mysquirrelbait.com/brain-scans-detect-fibromyalgia/

And below is a picture showing the darkened areas of the brain that would be bright and active in a normal person, but is not in those with Fibro. SPECT scan. I have become a real fan of brain scientist Daniel Amen. If you look up his research or his center to diagnose various brain issues, you will see that he uses the SPECT scan for every diagnosis, www.amenclinics.com/. here is the Mayo clinic's page on SPECT scans. http://www.mayoclinic.com/health/spect-scan/MY00233

Best wishes Dr. Quintner. Hoping to get to know you better here. I'll hope you'll stick around for a while. Your profile says your only advice is to negate this test. I hope you'll find more reasons to stay.


To be honest, Sheila, even if the test is just junk, we're still ahead, thanks to the research. Now we know that fibro affects the blood flow that regulates pain and reactions to it. We have proof that fibro does exist. So it's all good.

Of course it exists! If only it was not such a complex problem. Fortunately, I am not an expert but you may be interested in my ongoing dialogue with Professor Fred Wolfe on his blog - Fibromyalgia Perplex. The discussions there are honest and open. You will find an abbreviated version of our hypothesis paper, as well as extremely critical analyses of Topics such as Somatization and Myofascial Pain/Trigger Point theory. Good hunting.

Now there's a term my Chiropractor prefers over Fibromyalgia, 'Myofascial Pain Syndrome'. They read almost the same to me, MPS does not seem to be as controversial in the medical community.

Not controversial? Take a look on Professor Wolfe’s blog site and you will see the fallacious construct taken apart. Currently it serves only as a license for therapists to insert sharp objects into innocent muscle tissues. Evidence for any benefit therefrom is hard to find from the analyses conducted of the large number of trials that have been published!

Some self-styled Fibromyalgia experts are peddling the idea that input from Myofascial trigger points is responsible for persistent widespread pain of Fibromyalgia! Not a shred of evidence exists to support such speculation.

I can’t get more controversial than this!

http://www.fmperplex.com/

I believe this is the link that Dr Quintner is referring to.

http://www.medterms.com/script/main/art.asp?articlekey=9463

"Aporia, a space and presence that defies no access to it's secrets."I like this Dr Q!

I was finally able to print the article 'An Evolutionary Stress-Response Hypothesis for Chronic Widespread Pain (Fibromyalgia Syndrome'. This will allow me to better reference while I attempt to understand this. I had scanned it last night when we had our initial exchange. From what I could understand at that point, it was very similar to the definition given me by my Rheumatologist.

Here is my diagnosis to date:

Psoriatic Arthritis, Spondylitis type (Primary)

Sjogren's Syndrome,

Raynaud's Phenomenon,

Cervical Radiculopathy,

Spinal stenosis of the tailbone,

Costochondritis,

Sciatica,

Degenerative Disc Disease,

Degenerative Facet Disease,

Fibromyalgia,

Fibromyalgia is the most difficult for me to understand, but I believe that your article will change that for me.

The Chiropractor's diagnosis is MPS and RSD. The MD's do not agree with the RSD.

To date the very best treatment that has improved my health, my mobility and quality of life is Enbrel. The best physical activities are mild stretching and walking.

Thank you very much for this information, or any other that will further our understanding, we are most fortunate that you have joined our group and are willing to share your vast knowledge.

I used to work at the University of Washington as a research assistant, the bottom line of this study is that they lied by saying they had no association with those who would develop the test. Patents were being applied for even before the study came out. They did not follow proper research protocols and were very unethical. There are some who are calling for the researchers to pull the paper and stop marketing this test. Even if they were in a round about way on the right track for a FMS blood test would you actually want to give your money to a con artist who is playing on our hope and desperation.

It is my hope that maybe an ethical researcher could take this as well as the study about cytokines and create an honest

test for FMS. For me I will continue the fight until a legitimate test can be found hopefully in my lifetime.

JsMom