Proprietary FM/a Fibromyalgia Blood Test Claims Quick, High Accuracy Results

Proprietary FM/a Fibromyalgia Blood Test Claims Quick, High Accuracy Results

Fibromyalgia (FM) is a common and complex chronic pain disorder that causes widespread pain and tenderness to touch that may occur bodywide, or migrate over the body to a degree that it affects people physically, mentally, and socially. It is estimated that 2 to 8 percent, or as many as 20 million Americans, have fibromyalgia, with a ratio of about 8 to 2, women over men, but it can occur in people of all ages, including children.

nfmcpalogoThe National Fibromyalgia & Chronic Pain Association (NFMCPA), a nonprofit 501(c)(3) charitable organization, notes that while a literal translation of the term fibromyalgia is “pain in the muscles, ligaments and tendons,” fibromyalgia symptoms are typically more than pain and present in a wide range of phemomena that vary from person to person.

Patients with fibromyalgia typically display diffuse hyperalgesia (increased response to painful stimuli) or allodynia (heightened sensitivity to stimuli that are not normally painful). Other fibromyalgia symptoms can include debilitating fatigue, sleep disturbances (sleep apnea or waking up unrefreshed), cognitive difficulties (memory problems or thinking clearly), and joint stiffness. Other common symptoms may include depression or anxiety, migraines, tension headaches, pelvic pain, irritable or overactive bladder, irritable bowel syndrome (IBS), TMJD (including tinnitus), and gastrointestinal reflux disease.

In the past, such syndromes have been called fibrositis, nonarticular rheumatism, chronic fatigue syndrome, myodysneuria, fibromyositis, muscular rheumatism, and more, and fibromyalgia has been considered a rheumatologic disorder based on the assumption that it is a type of inflammatory fibro-connective dysfunction.

Conventionally, fibromyalgia has been a diagnosis of exclusion in the absence of specific laboratory tests or radiographic or imaging studies, with the only physical finding currently used in diagnosing fibromyalgia being excess tenderness on palpation of soft tissues. Patients commonly spend many years seeking confirmation of the disorder.

Healthcare providers diagnose fibromyalgia based on a combination of subjective symptoms, such as how the person feels, including fatigue, tenderness, functionality, and overall well-being. Lab tests may be ordered to rule out or diagnose co-existing conditions such as lupus, thyroid hormone resistance, or rheumatoid arthritis. This lack of an objective test to either confirm or rule out the a diagnosis of fibromyalgia has often resulted in patients being labeled neurotic, hypochondriacs, or emotionally unstable.

Connie A. Luedtke, R.N., nursing supervisor of the Fibromyalgia and Chronic Fatigue Clinic at the Mayo Clinic in Rochester, Minnesota, observes that the top misconception many people have is that fibromyalgia isn’t a real medical problem or that it’s all in the patient’s head, noting that while there’s still much that’s unknown about fibromyalgia, researchers have learned more about it in just the past few years.

clauwDIn a 2014 article titled “Fibromyalgia: A Clinical Review,” published in the Journal of the American Medical Association (JAMA), Daniel J. Clauw, M.D., a professor of anesthesiology, medicine (rheumatology), and psychiatry, and director of the University of Michigan’s Chronic Pain and Fatigue Research Center in Ann Arbor, notes that based on a meta analysis of medical literature on fibromyalgia from 1955 to March 2014 reviewed on MEDLINE and the Cochrane Central Registry of Controlled Trials, with an emphasis on meta-analyses and contemporary evidence-based treatment guidelines, “Fibromyalgia and other ‘centralized’ pain states are much better understood now than ever before, [and] fibromyalgia may be considered as a discrete diagnosis or as a constellation of symptoms characterized by central nervous system pain amplification with concomitant fatigue, memory problems, and sleep and mood disturbances.”
BehmFIn 2013, Los Angeles, California-based biomedical company EpicGenetics Inc. debuted its proprietary FM/a – The Fibromyalgia Test, a multi-biomarker-based test developed based on results of a clinical scientific study conducted by a research team at the University of Illinois College of Medicine at Chicago led by Prof. Frederick Behm, head of the Department of Pathology.

The FM/a test analyzes immune system white blood chemokine and cytokine patterns. Patients with fibromyalgia have a significantly dysregulated pattern in these proteins. Results of Behm’s University of Illinois study were published in 2012 in the journal BMC Clinical Pathology in an Open Access article, “Unique immunologic patterns in fibromyalgia,” co-authored by Behm and Igor M. Gavin, Oleksiy Karpenko, Valerie Lindgren, Sujata Gaitonde, Peter A. Gashkoff, and Bruce S. Gillis.

The researchers observe that recent data point to the role of the immune system in FM, with aberrant expressions of immune mediators such as cytokines being linked to fibromyalgia pathogenesis and traits. They determined whether cytokine production by immune cells is altered in fibromyalgia patients by comparing cellular responses to mitogenic activators of stimulated blood mononuclear cells in a large sampling of patients with fibromyalgia to those of healthy matched individuals.

The investigators found cytokine levels of stimulated PBMC cultures of healthy control subjects were significantly increased compared to matched non-stimulated PBMC cultures, while in contrast, concentrations of most cytokines were lower in stimulated samples from patients with FM compared to controls. They conclude that cytokine responses to mitogenic activators of PBMC isolated from patients with fibromyalgia were significantly lower than those of healthy individuals, which implies that cell-mediated immunity is impaired in fibromyalgia patients, with their novel cytokine assay revealing unique immunologic traits which, when combined with clinical patterns, can provide a diagnostic methodology for fibromyalgia.

The authors observe that because FM syndrome by definition lacks consistent patterns regarding pain intensity, many have claimed it to be a a rheumatologic, neurologic, or psychiatric disease, despite the fact there were no objective links to any of those pathways. However, they report that their findings uncovered evidence that fibromyalgia is actually an immunologic disorder, with the immunologic basis occurring independently of any subjective features, underscoring the strong clinical value of their test protocol, and observing that individual cytokines exhibiting similar dynamics in patient samples reveals that FM patients are uniform in regard to their cellular immunologic responses.

Researchers conclude that aberrant responses of levels of a large number of cytokines of in vitro stimulated PBMC using the methodology employed in their study is significantly correlated with a clinical diagnosis of FM, and further provides a useful confirmation of the clinical diagnosis of fibromyalgia. They suggest that this method of evaluating cytokines levels in stimulated PBMC may prove useful in analyzing specific responses to therapeutic modalities and medications in order to determine their efficacy.

WallaceDEpicGenetics notes that Prof. Daniel Wallace of the UCLA Geffen School of Medicine led a research team in a nearly 500-patient study of immune system biomarkers in reference to fibromyalgia, the results of which he presented at the 2013 annual conference of the American College of Rheumatology and which were published in the journal Rheumatology International. (Disclosure: Dr. Gillis personally underwrote the study and owns EpicGenetics. Dr. Wallace was a consultant for EpicGenetics in 2013. Dr. Gavin, Karpenko and Barkhordar are employees of EpicGenetics).

EpicGenetics says the findings of Wallace’s group that the fibromyalgia biomarkers that make up the FM/a test do not occur in other rheumatic diseases such as rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE) have been re-confirmed in a second laboratory.

EpicGeneticslogoEpicGenetics’ proprietary FM/a – The FM Test is a laboratory-developed test (LDT) that was created and is performed in their laboratory in California, which is Clinical Laboratory Improvement Amendments-certified and accredited by the College of American Pathologists (CAP). The CAP accreditation is an internationally recognized program that goes well beyond regulatory compliance and helps laboratories achieve the highest standards of excellence to positively impact patient care. The FM/a test fulfills the FDA regulation for immunological test systems.

FM:alogoThe company  observes that that FM/a – The FM Test is the first objective test to diagnose fibromyalgia using a simple blood test, with results usually available in a week — a fraction of the time and money patients typically spend seeking a diagnosis. The FM/a test is a multi-biomarker test based on immune system white blood chemokine and cytokine patterns; patients with fibromyalgia have a significantly dysregulated pattern regarding these proteins. Test results are based on a 1-100 scoring system, with fibromyalgia patients having scores higher than 50.

EpicGenetics claims the test’s sensitivity for fibromyalgia approaches 93 percent and its specificity exceeds 90 percent — a degree of certainty comparable to that of the HIV blood test. By comparison, they note that the rheumatoid arthritis blood test is only 50 percent sensitive, and no medical test is 100 percent accurate.

To order the FM/a test, patients must obtain a doctor’s authorization through a Doctors Authorization Form, as well as insurance plan information on the Patient Information Form. Both forms can be downloaded from the EpicGenetics FM/a website.

The company notes that that many insurance carriers, including Blue Shield of California and Medicare, are now reimbursing for FM/a test, and EpicGenetics will assist patients at no cost to determine whether their insurance or Medicare coverage and benefits will pay for the cost of the test. They note that many companies also offer Flexible Spending Accounts (FSA) or Healthcare Savings Accounts (HSA) to help employees pay for medical expenses not covered by their insurance, including lab services. Since FM/a falls under medical laboratory tests, these costs can qualify for FSA/HSA reimbursement. If your company offers an FSA/HSA program, plan ahead and consult your benefits department. When it comes time to enroll in your program, you can authorize a deduction for the appropriate amount.

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