FM/a® – The Fibromyalgia Test, is manufactured by EpicGenetics, Inc., a privately-held biomedical company based in Los Angeles, California. It was developed based upon a clinical scientific study which was accomplished by a research team at the University of Illinois College of Medicine at Chicago which was led by Professor Frederick Behm, Department Head of the Department of Pathology. Their peer-reviewed, published manuscript is available in full at: BMC Clinical Pathology.
The findings of Professor Behm’s team led the prestigious American Association for Clinical Chemistry to bestow their “Outstanding Research in Clinical Immunology” award to this group for their scientific discovery.
Subsequently, Professor Daniel Wallace of the UCLA Geffen School of Medicine, a world renown rheumatologist and expert in fibromyalgia with multiple textbook publications led a research team in a nearly 500 patient study of immune system biomarkers in reference to fibromyalgia. Those results were presented by Professor Wallace at the 2013 annual conference of the American College of Rheumatology and were published in a peer-reviewed medical journal, which is available at Rheumatology International
. The findings of Professor’s Wallace group re-confirmed in a second laboratory the original discovery from the University of Illinois College of Medicine and they demonstrated 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).
FM/a® is a Laboratory-Developed Test (LDT) that was developed — and is performed — in a CLIA certified and CAP accredited laboratory. The test fulfills the FDA regulation (21CFR 866.5700) for an immunological test system.