Reprinted with the kind permission
of Cort Johnson and Health Rising.
A blood test is like the holy grail for contested diseases like fibromyalgia (FM) 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 EpicGenetics believes it has one. The shocker?
It’s an immune test for this putative central nervous system disorder.
“What we are able to say unequivocally is that there is this unique immune system set of biomarkers in Fibromyalgia.” Dr. Bruce Gillis
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 (IL-6), interleukin-8 (IL-8), macrophage inflammatory protein-1 alpha (MIP-1a) and macrophage inflammatory protein-beta (MIP-1b), produced in response to mitogenic stimulation.
They were 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, 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 its 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.
Subscribe to the World's Most Popular Newsletter (it's free!)
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 but there is something about the blood that’s different. A blood test, if it really got around, just might do it.
EpicGenetics, the manufacturer of the test, believes similarly. It states:
FM/a® reveals that this disorder, whether called fibromyalgia, fibrositis, the chronic fatigue syndrome or fibromyocitis, among other names, is really an immune system dysregulation disease. Patients who test positive for FM/a® will no longer be labeled neurotic, hypochondriacal chronic complainers. Theirs is an actual illness with objectively measurable traits.
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 United Healthcare, 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 company’s bottom line is positively affected if they can get FM patients diagnosed as quickly as possible.
EpicGenetics, 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 patient’s 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. 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.
Note: Health Rising is not affiliated with EpicGenetics.
About the Author: ProHealth is pleased to share information from Cort Johnson. Cort has had ME/CFS for over 30 years. The founder of Phoenix Rising and Health Rising, he has contributed hundreds of blogs on chronic fatigue syndrome, fibromyalgia and their allied disorders over the past 10 years. Find more of Cort’s and other bloggers’ work at Health Rising.