By Karen Lee Richards
For too many years, people with fibromyalgia have been forced to deal with medical professionals, family and friends who don’t believe fibromyalgia is a real medical illness. Gradually over the past 15 years, more and more people, including doctors, have accepted the fact that FM is a very real biological condition – helped in large part by the FDA’s approval of three drugs to treat FM.
Despite the progress, however, it still takes an average of three to five years – and according to the Journal of Managed Care Pharmacy, between $4,800-$9,300 annually – for someone with FM to get an accurate diagnosis. And there are still far too many doctors who remain skeptical even though multiple studies have demonstrated some of the biological underpinnings of FM.
Needless to say, a simple blood test that can definitively diagnose fibromyalgia would be a huge boon to the millions who suffer daily with this painful illness. If nothing else, it should put and end to all of the skepticism about FM.
Enter EpicGenetics, a company who, according to their Website, “is a leader in the field of molecular diagnostics.” On March 4, EpicGenetics issued a press release announcing the first test to objectively diagnose fibromyalgia. The test was developed in conjunction with a study that identified unique immunologic patterns in FM patients.
The Research Behind the Test
In a study published December 17, 2012 in the journal BMC Clinical Pathology, researchers measured plasma cytokine levels in a group of 110 patients with a diagnosis of FM and determined responses to mitogen challenges of their peripheral blood mononuclear cells (PBMC). The cytokine levels of these patients were then compared with those in a group of 91 matched healthy controls.
The found that cytokine levels of stimulated PBMC cultures of healthy control subjects were significantly increased as compared to matched non-stimulated PBMC cultures. In contrast, the concentrations of most cytokines were lower in stimulated samples from patients with FM compared to controls.
“The result was the discovery of a major set of differences in cell-mediated immunity in the fibromyalgia group versus the healthy patients.” said Bruce S. Gillis, MD, MPH, member of the clinical faculty at the University of Illinois Chicago College of Medicine and founder of EpicGenetics, in the March/April 2013 issue of Fibromyalgia and Chronic Pain Life. “And this discovery was opposite to what was anticipated. Specifically, while fibromyalgia patients are often considered to be “hyper/overactive responders,” we identified that the fibromyalgia patients had a depressed and dysregulated immune system…”
Another Significant Conclusion
Up until now, FM has had somewhat of a confusing history, being assigned to a variety of medical specialties. At first it was thought that FM was a rheumatologic disorder because it seemed to be some type of inflammatory fibro-connective problem. Then when it was discovered that FM had some central nervous system abnormalities, it was thought to be more of a neurologic disorder. The current hypothesis is that “FM develops from interactions between the autonomic central nervous system, the hypothalmic-pituitary axis and the immune system.
According to Dr. Gillis, in addition to developing the test, the study also revealed that “there is a specific pathway in fibromyalgia – and it defines fibromyalgia as an immunologic medical disorder.”
This study and the resulting test are certainly interesting and potentially very exciting, but there remain some unanswered questions and concerns.
- In the discussion portion of the study, it was noted, “Chronically depressed patients are characterized by higher pro-inflammatory cytokine blood levels and lower anti-inflammatory cytokine levels in blood, similar to what has been found in patients with chronic pain. Decreased IL-10, IL-1? and IFN-? production by mitogen-stimulated PBMC was observed in depressed patients which correlated with our findings.” The question is, would this test be able to distinguish between depression, other chronic pain conditions and fibromyalgia?
- 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 immunologic disorder as well?
- Finally, we have to keep in mind that this was just one study. Studies need to be replicated before they they can be accepted as absolute scientific fact. Just a little over three years ago, we thought that the cause of ME/CFS (chronic fatigue syndrome) was discovered when a study found the retrovirus XMRV in ME/CFS patients. A test to detect XMRV was quickly brought to market. Unfortunately, after many additional studies, the original findings were retracted.
Hopefully, this study and test will hold up to further testing that includes other cohorts in addition to healthy controls. Only time will tell.
Info About the FM Test
The FM/a Test Kit can be ordered 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.
The FM/a Test 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, although EpicGenetics says they will work with patients to try to get as much reimbursement as possible for the test from their insurance companies.
Sources: BMC Clinical Pathology, December 17, 2012. By Frederick G. Gehm, Igor M. Gavin, Oleksiy Karpenko, Valerie Lindgren, Sujata Gaitonde, Peter A. Gashkoff, and Bruce S. Gillis. Department of Pathology, University of Illinois at Chicago (UIC), Chicago, IL, USA. E-mail: email@example.com