The recent study published in BMC clinical Pathology and held by the University of Illinois College of Medicine at Chicago (UIC) and EpicGenetics revealed research that has led to a to the first objective diagnostic test for fibromyaglia. This will significantly reduce the wait time for diagnosis in patients. However was the test put to market too quickly without enough validating research?
The study involved a total of 110 fibromlaygia patients and 91 healthy control subjects. The study found “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 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.” BMC Clinical Pathology December 17, 2012 According to Markewatch this suggests that patients with FM have a “dysregulation disorder affecting protein molecules called chemokines and cytokines, produced by white blood cells. While fibromyalgia patients have been classified to be hyperactive (or overactive) responders, the study showed that people with fibromyalgia have immune production patterns which may make them more vulnerable to stress, thereby leading to chronic pain, severe fatigue, diffuse muscle tenderness, insomnia, and other unbearable symptoms long associated with fibromyalgia.”
They state the research has identified specific diagnostic biomarkers for fibromyalgia that has led to their ability to come up with this diagnostic tool. Given patients can wait up to five years or more and undergo numerous tests while determining diagnosis this will indeed come to a relief to some people. Often with FM it seems like this process of elimination. Eliminate other diseases and then you end up with a diagnosis of fibromyalgia, however one your doctor may be skeptical of without that actually test to verify it with fool proof evidence. This will be that piece of evidence that will hopefully provide patients with what they need to get proper attention from their doctors.
“The elegantly designed study by Dr. Gillis and his co-investigators represents a milestone on the path our group charted 25 years ago when we first hypothesized that cytokines play a role in fibromyalgia(2). It is hoped that this and future work sponsored by EpicGenetics will lead to a greater understanding of how the immune system, fatigue, sleep disorders, chronic stress and pain interact in patients with fibromyalgia and related disorders," said Daniel J. Wallace MD, FACP, FACR, a clinical professor of medicine at the David Geffen School of Medicine at UCLA based at Cedars-Sinai Medical Center, and a member of the Scientific Advisory Board of EpicGenetics. “ Marketwatch
The test itself it simply a blood test and it is said to be 93% sensitive and is available as of March 4th, 2013. The cost of the test will be $744. Patients will be required to fill out a questionnaire of their symptoms to see if they qualify for it which can be arranged with their doctor. Currently the FM test is done available only through EpicGenetic. If you live outside of the United States and have questions about this test, other questions or want there contact information please contact: www.thefmtest.com or www.epicgtx.com or call 855-775-FIBRO.
Issues
First of all the study has not been replicated. Previous studies have not shown this result so having a study to replicate this data would go a long way to validate the information prior to using it as a diagnostic tool.
The study compared fibromyalgia patients to healthy controls. It is possible these cytokine results might occur in other pain conditions but since the study does not look at other illnesses we do not know if these markers show up elsewhere. It would be hasty to rush to use this diagnostically if the result may indicate more than one pain condition. A comparative study to see if the cytokine findings show in other pain conditions or if levels differ in other pain conditions would have been important to establish the validity of a test to diagnose FM with such accuracy. Patients often have more than one illness and at times more than one pain condition, if cytokine levels are different in these conditions as well a patient could show they have FM when in fact they do not.
Thirdly, patients in the study had been diagnosed with fibromyalgia for at least one year. Does this indicate cytokine findings are something found immediately when someone develops fibromyalgia or is this itself something that develops as the syndrome progresses? If it takes three to five years to be diagnosed would these findings be found in those early patients as well?
Since the study was done on patients off their medication one does wonder if the test will be effected by those medication uses by patients. Does treatment improve their cytokine levels? Would medications affect the results?
Conclusion
The diagnostic test came out quite rapidly after the study was produced and was perhaps a bit hasty. In fact, given cytokine levels can be abnormal in other physical conditions and this was not explored it can be said the sudden market production of this test was rather hasty indeed without follow-up studies. However with a specialist doing their due diligence, the questionnaire and the blood test combined there should be no issues. The blood test then is more a validation of what the specialist would already diagnose. Proof for the patients doctor or one day even insurance companies. As long as you are aware the test itself may point to other conditions as well. Is the test necessary? Not at all. It will cost you money and it is money your insurance company is not likely to reimburse you for. There has always been that issue with FM that it is difficult to diagnose, often misdiagnosed and there is no 'yes' or 'no' sure fire blood test to prove it. If that is an issue, then certainly this is a solution. It is just a solution that is not necessary to diagnosis and you will pay out of pocket to have that extra validation.
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