Anyone who has experienced severe, chronic pain knows the long process it takes to get a correct diagnosis. Many people see an average of 5-6 specialists before getting a definitive diagnosis. Fibromyalgia, a chronic pain disorder of unknown etiology, causes widespread pain, sleep disturbances, severe fatigue, cognitive problems (“brain fog”) and often depression and anxiety. Diagnosis of fibromyalgia is often based on the exclusion of other diseases that cause muscle and joint pain including autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematosus. The American College of Rheumatology designated 18 tender points (9 pairs) where a physician places pressure for four seconds to test the level of pain present. Lab tests checking for hypothyroidism, muscle myopathies, chronic infections, and autoimmune diseases help to rule out other possible conditions.
In 2012, the FDA approved the first laboratory test for fibromyalgia. The FM/a test, produced by EpicGenetics, requires a small amount of blood that is analyzed for chemokine and cytokine biomarkers, which have been found to be abnormal in people with fibromyalgia. The test is considered to be diagnostic of fibromyalgia if the result is above 50.0.
Researchers at the University of Illinois College of Medicine at Chicago designed a study with a small number of fibromyalgia patients to analyze their immune system functions, which were then compared to healthy controls. The study resulted in the discovery that fibromyalgia has depression of cell-mediated immunity, which was opposite to the anticipated results. Up until that point, fibromyalgia was thought to be a hyperactive/overactive disorder. After two years of testing fibromyalgia and healthy patients, they found unique immune system patterns.
The results of this study ultimately led to the development of the FM/a test with a 93% sensitivity, and it finally gave legitimacy to fibromyalgia as a disease as well as people suffering from it who have been dismissed and told they are exaggerating their symptoms. Daniel J. Wallace, MD, FACP, FACR, associate director of the Rheumatology Fellowship Program at Cedars-Sinai Medical Center as well as managing physician of the EpicGenetics Clinical Testing Program stated “The significance of this breakthrough will change the way the medical community views fibromyalgia, as well as how doctors diagnose, and ultimately manage patients with the condition. This discovery provides hope and validation for millions of fibromyalgia sufferers.”
In 2013, a new research study was performed jointly at Cedars-Sinai Medical Center in Los Angeles and the University of Illinois College of Medicine at Chicago that was designed to test the specificity of the FM/a test for fibromyalgia versus rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). The data from this study indicated that “lowered cytokine/chemokine profiles from stimulated PBMC may represent a biomarker that is relatively sensitive and specific for FM compared to SLE and RA.”
The FM/a test gives people a way to finally be diagnosed with fibromyalgia avoiding years of unnecessary tests. Effective treatments to control the symptoms of fibromyalgia can be initiated earlier avoiding medications that are not indicated for the disease. The test comes as a blessing is to people who have not been able to give their pain and fatigue a name.