SANTA MONICA, Calif.--(BUSINESS WIRE)--A recent peer-reviewed study, published in BMC Clinical Pathology, reveals a medical breakthrough discovering multiple biomarkers based upon highly sensitive and reproducible medical investigations. Conducted by the University of Illinois College of Medicine at Chicago (UIC) and EpicGenetics, a privately-held biomedical company, the research has led to the development of The FM/a® Test (www.thefmtest.com), the first test to objectively diagnose fibromyalgia.
Researchers at the UIC Department of Pathology conducted a statistically significant study involving more than 200 patients, comparing those clinically diagnosed with fibromyalgia to healthy patients. The study revealed that patients with fibromyalgia 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. Evaluation of The FM Test patient results will provide a continuing database that could lead to further insight into what may cause and exacerbate fibromyalgia and permit the development of standards to determine effective treatments.
EpicGenetics worked with fibromyalgia support groups to recruit participants in the clinical research study and is collaborating with groups such as the National Fibromyalgia & Chronic Pain Association to educate the fibromyalgia community and others about the availability of The FM Test.
“The results of our research have allowed us to ‘pull back the curtain’ and identify specific diagnostic biomarkers in fibromyalgia,” said Bruce S. Gillis, MD, MPH, member of the clinical faculty at the UIC College of Medicine and founder of EpicGenetics. “For decades, the medical community has viewed fibromyalgia with much skepticism. Patients have been stigmatized, and many are spending thousands of dollars and years of frustration in search of a diagnosis. Our breakthrough provides patients with hope and validation that their symptoms are real, and we hope physicians who commonly see patients with fibromyalgia will embrace and value this test for its role in the advancement of medical care.”
According to the American College of Rheumatology, fibromyalgia affects more than 12.3 million people in the United States, comparable to the number of people affected by cancer. Patients who experience symptoms, such as chronic pain and fatigue, depression and insomnia, spend an average of three to five painful years seeking a diagnosis and $4,800-$9,300 annually on associated medical costs. Until now, there has been no conclusive test to confirm the diagnosis of fibromyalgia.
The FM Test, a simple blood test with more than 93 percent sensitivity, now makes it possible for anyone to find out if they have fibromyalgia. The FM Test costs $744 with conclusive results available to most patients usually in a week or less – a fraction of the time and money the average patient currently spends seeking a diagnosis.
By completing a simple symptoms questionnaire at www.thefmtest.com, patients and their doctors can find out if they qualify for the test. If a patient meets the requirements, they can arrange for the test at their doctor’s office or at an independent blood draw facility.
“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 fibromyalgia2. 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.
1 The full study may be found at: http://www.biomedcentral.com/1472-6890/12/25
2 D Wallace et al, Annals of Internal Medicine, 1988; 108: 909.
Based in Santa Monica, Calif., EpicGenetics (www.epicgtx.com) was founded in 2010 by Bruce S. Gillis, MD, MPH, as a privately-held biomedical company, dedicated to developing conclusive diagnostic medical tests for complex medical conditions where no definitive testing is currently available.
With this specialized focus, EpicGenetics created the first objective diagnostic test for fibromyalgia – The FM/a® Test (www.thefmtest.com). The American Association for Clinical Chemistry recognized Dr. Gillis and the fibromyalgia research team for “Outstanding Research in Clinical and Diagnostic Immunology” in 2012. The FM Test is a quick, simple blood test which makes it possible for anyone to objectively find out if they have fibromyalgia, usually in a week or less.