Many marginalized and doubted fibromyalgia patients would have had an easier journey through the medical system if there was only a simple blood test to help diagnose their fibromyalgia condition. And there may be! But don't believe everything you read.
The Center for Disease Control and Prevention (CDC) states that fibromyalgia (FM) affects about 4 million US adults, about 2% of the adult population. (1) It is more likely to occur as people age and women seem more likely to develop it than men, as are persons with certain auto-immune diseases, repetitive injuries or traumatic events. To date, a singular clear cause for fibromyalgia is not known.
While trying to get treatment and help for their condition, or even just a diagnosis so that they may receive help for their condition, many patients with FM are met with skepticism by employers, friends, family, and the medical community. That is why Epicgenetics Inc., the company behind the FM/a® test, advertise it on their webpage as "Know the truth once and for all. And prove it to your boss, family and friends, and healthcare providers."(2) This is enticing, and fair given the history around this condition.
“Facts are stubborn things, but statistics are pliable.” ― Mark Twain
But the first thing that caught my critical eye on their website was the statistics presented. Statistics, really? I know, I know. But having just authored material on FM, I am very familiar with the currently reported prevalence among our population. So it surprised me to read: "As many as 28 million Americans have the chronic medical disease known as fibromyalgia. ... An estimated 95% of people with fibromyalgia remain undiagnosed today." (3) I could not find any reference to justify the numbers they provided and remain unsure why they went for a dataset so far from what is recognized by the CDC.
So naturally this just led me to be more inquisitive of Epicgenetics, Inc. when I read the claim that it "... is the first and currently the only definitive blood test to objectively diagnose FM." (4) For though this sounds great, the National Institutes of Health (NIH) states very clearly on their webpage dedicated to FM that "[c]urrently, there are no specific laboratory or imaging tests for FM." (5) So what are we to make of this?
The Trend Away From Objective Testing
At this writing, the most recent diagnostic criteria for FM have moved away from clinician-identified physical points to be much more patient-focused, by allowing for broader criteria with a notably subjective character. A diagnosis of FM requires that multiple criteria be met including: (6)
· Multisite pain (6/9 body areas, present at least three months)
· Sleep problems OR fatigue
· These criteria additionally highlight the role of environmental sensitivity in FM by including it in four common features (along with tenderness, dyscognition, and musculoskeletal stiffness), which may be used to support the diagnosis of FM.
However, this test may move things in a different direction!
A Closer Look at the FM/a® Test
The test requires that a clinician ask the FM/a®'s manufacturer that a patient be considered for approval to have the test done. At least in early 2021, patients had to exhibit "at least four of the typical symptoms of FM". If approval is given, then Epicgenetics, Inc. will send the collection kit and instructions to the patient, with a phlebotomy sample potentially able to be drawn by local labs like Quest Diagnostics. The cost of the test for people without health insurance assistance is reportedly $1,080. (7) Once the test is completed, the company may invite the patient to volunteer for clinical treatment trials approved by the Food and Drug Administration (FDA).
Now, there is nothing inherently wrong with a laboratory test which siphons participants directly into a clinical study, as many people may be seeking such opportunities for further relief. But it is worth noting that clinicians cannot freely order this test for their patients, rather, their requisition has to be approved by a company, which seems to be only allowing specific people and symptom sets to try it. And this may be to better preserve a specific clinical sample set, which then more reliably is consistent with the abnormal immunologic cytokine and chemokine profiles published about in 2012 and 2015, upon which this test is based. And this may be the best way to help preserve such impressive diagnostic claims as "100% accuracy in identifying that immune system deficiency." (2) But admittedly, I have had no dialogue with the laboratory and do not know definitively the reasoning for their policies and procedures.
Significantly Lower Levels of Chemokines and Cytokines may be an Indicator of FM
So what is the research from 2012 and 2015 upon which this test was based?
In 2012, a team of researchers published 'Unique Immunologic Patterns in Fibromyalgia' which sought to elucidate the role of the immune system in FM. (8) Immune mediators, such as cytokines, had already been linked to the pathogenesis and traits of FM, so they sought out to determine whether cytokine production by immune cells is altered in FM patients, by comparing the cellular responses to specifically stimulated white blood cells. The white blood cells selected, called 'mononuclear cells', were compared between some two hundred patients with FM and healthy individuals. Unlike most previous studies, rather than measuring serum levels, peripheral blood mononuclear cells (PBMC) were stimulated and then measured.
The findings were impressive. The cytokine concentrations of IFN-γ, IL-5, IL-6, IL-8, IL-10, MIP-1β , MCP-1, and MIP1-α, in plasma as well as in PBMCs, were determined and found to be, among healthy control subjects "... significantly increased" while, "[i]n contrast, the concentrations of most cytokines were lower in stimulated samples from patients with FM compared to controls. The decreases of cytokine concentrations in patients samples ranged from 1.5-fold for MIP-1β to 10.2-fold for IL-6 in PHA challenges. In PMA challenges, we observed 1.8 to 4-fold decreases in the concentrations of cytokines in patient samples."(8) In conclusion, the cytokine responses to cellular stimuli activators of PBMC isolated from patients with FM were significantly lower than those of healthy individuals, implying that cell-mediated immunity is impaired in FM patients.
Another piece of research specifically referenced by the FM/a® is a paper published in 2015 which sought to differentiate chemokine and cytokine profiles of FM from those of two auto-immune conditions, rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). (9) This was a notable undertaking since people with these auto-immune conditions are more at risk of having FM, though the conditions remain distinct from one another. This study undertook comparative analyses to test the hypothesis that inflammation (represented by RA and SLE) and central sensitization syndromes (represented by FM) have distinct cytokine/chemokine signatures that could be clinically relevant.
Their findings showed exactly that! PBMCs were used as in the previous study. "Ninety-three percent with FM scored positive compared to only 11% of healthy controls, 69% RA or 71% SLE patients had negative scores. The sensitivity, specificity, positive predictive and negative predictive value for having FM compared to controls was 93, 89, 92 and 91%, respectively. Evaluating cytokine and chemokine profiles in stimulated cells reveals patterns that are uniquely present in patients with FM." (9)
In conclusion, the FM/a® test is founded on great research which gives insight into some of the mechanisms for the condition, and how it is separate from healthy norms or inflammatory auto-immune conditions. It tests the concentration of chemokines and cytokines within a person's blood sample and gives a score of 1-100, with a positive at or above 50. So it is not the test itself, but some of the marketing and procedural entrappings around it, which may be reason to give some people pause.
Interestingly, the serum test FM/a®, yet to be FDA approved, is covered by some insurance plans, including Medicare, according to the company EpiGenetics, Inc.
Ryabkova, Varvara A et al. “Neuroimmunology: What Role for Autoimmunity, Neuroinflammation, and Small Fiber Neuropathy in Fibromyalgia, Chronic Fatigue Syndrome, and Adverse Events after Human Papillomavirus Vaccination?.” International journal of molecular sciences vol. 20,20 5164. 18 Oct. 2019, doi:10.3390/ijms20205164.
The content and any recommendations in this article are for informational purposes only. They are not intended to replace the advice of the reader's own licensed healthcare professional or physician and are not intended to be taken as direct diagnostic or treatment directives. Any treatments described in this article may have known and unknown side effects and/or health hazards. Each reader is solely responsible for his or her own healthcare choices and decisions. The author advises the reader to discuss these ideas with a licensed naturopathic physician.