Diagnostic Blood Test Developed for Fibromyalgia

Cytokine-producing activity of immune cells of fibromyalgia (FM) patients has led to the development of a commercial blood test.

The very real biological condition of FM takes an average of three to five years for someone with the illness to get an accurate diagnosis as hitherto there was no diagnostic blood test to definitively confirm the disorder.

The blood test was developed in conjunction with a study that identified unique immunologic patterns in fibromyalgia patients. Scientists at the University of Illinois at Chicago (UIC; IL USA) 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.

A custom panel of antibody-conjugated beads for measuring eight human cytokines (BioRad Laboratories; Hercules, CA, USA) was used in the assay. The investigators that cytokine levels of stimulated PBMC cultures of healthy control subjects were significantly increased as compared to matched nonstimulated PBMC cultures. In contrast, the concentrations of most cytokines were lower in stimulated samples from patients with FM compared to controls.

The FM Test is the first test to objectively diagnose fibromyalgia via a simple blood test, with results usually available in one week or less. The FM Test was developed by EpicGenetics (Santa Monica, CA, USA), and will cost USD 744. The FM test is a multi-biomarker-based assay, which comprises immune system white blood cell chemokine and cytokine patterns. Patients with fibromyalgia have a significantly dysregulated pattern regarding these proteins. Test results are based upon a 1-100 scoring system, with fibromyalgia patients having scores of 50 and above. The FM Test is more than 93% sensitive and by comparison, the rheumatoid arthritis blood test is only 65% sensitive.

Bruce S. Gillis, MD, MPH, the founder of EpicGenetics, said, “The result was the discovery of a major set of differences in cell-mediated immunity in the fibromyalgia group versus the healthy patient, 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.” The original study the test was based on was published on December 17, 2012, in the journal BMC Clinical Pathology.

Related Links:
University of Illinois at Chicago
BioRad Laboratories
EpicGenetics