University of Illinois College of Medicine researchers may have discovered the genetic signature of fibromyalgia . Phase two of the genomics study is currently underway in an attempt to validate their initial finding.
“If we do identify the genomics of fibromyalgia, we will be aware of the cause of the disease, have a more precise target for treatment, be able to prove once and for all and unequivocally that fibromyalgia is an actual medical disease, be able to do genetic screening of prospective parents and change forever the paradigm regarding fibromyalgia,” says Dr. Bruce Gillis, CEO of EpicGenetics, a Los Angeles-based biomedical firm that’s partnering with the university on the genomics project.
Fibromyalgia Test Creators Partnering on Genomics Project
EpicGenetics is the creator of the controversial FM/a blood test  for fibromyalgia. The test has been on the market since 2012, but the American College of Rheumatology and most top fibromyalgia researchers have not endorsed the test as a valid diagnostic tool. Critics have said not enough study has been done on the test to prove it is indeed diagnosing fibromyalgia .
However, in recent years, a growing number of insurance companies have begun to cover the test, and more and more physicians are using it to help in the diagnosis of fibromyalgia.
Previous EpicGenetics studies showed fibromyalgia patients have reduced levels of four specific chemokines and cytokines, signifying suppression of the immune system.
Is Fibromyalgia an Immune System Problem?
“We believe [the term] fibromyalgia is a misnomer,” Gillis says. “These people aren’t suffering with anything that’s affecting the muscles, per say. What they are suffering with is their immune system cannot produce normal quantities of protective proteins. …There are cells in the immune system called peripheral blood mononuclear cells. They are not producing normal quantities of the protective proteins called chemokines and cytokines.”
In 2017, EpicGenetics announced it would seek approval from the Food and Drug Administration (FDA) to conduct a clinical trial in which the Bacille Calmette-Guerin (BCG) tuberculosis vaccine would be administered to patients as a potential treatment for fibromyalgia . The BCG vaccine has been used for nearly 100 years and given safely to millions of people around the world.
During the upcoming BCG trial, patients will be given three doses of the vaccine over a two-year period. The intent is not to prevent fibromyalgia, but to restore proper functioning of the immune system, which should hopefully result in the reversal of most fibromyalgia symptoms .
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EpicGenetics had planned to start the BCG trial earlier this year, but Gillis made the decision to delay it after University of Illinois researchers found a promising DNA pattern for fibromyalgia during their genomics project.
“The genomics study is now taking priority because of the results we achieved,” Gillis says. “Hopefully, the second phase [of the genomics study] will corroborate what we saw in the first phase. The most important thing is not merely administering the vaccine, but having a methodology to monitor its efficacy. If we have some genomic patterns we need to follow, then we want to have that information before we start administering the vaccine.”
Who Qualifies to Take Part in the Studies?
All patients who have tested positive for fibromyalgia using the FM/a test are eligible to participate in the University of Illinois genomics study. They will also qualify to possibly take part in the BCG vaccine study.
EpicGenetics hopes to move forward with the BCG trial by the end of this year. The FDA has approved Massachusetts General Hospital in Boston as the primary site to conduct the BCG trial. EpicGenetics is seeking approval for additional trial sites around the country.
Those who are interested in taking the FM/a test and possibly participating in the genomics and BCG studies should visit FMtest.com or call (310) 268-1001 between 9 a.m.-5 p.m. PST for more information.
Medicare and some private insurers pay for the FM/a fibromyalgia test on a case-by-case basis. EpicGenetics offers a no-interest payment plan for patients who are uninsured or whose insurance will not cover the test.
On the Cusp of Proving Fibromyalgia Is Real
“We are cautiously optimistic that we are on the throes of a breakthrough in better understanding fibromyalgia,” Gillis says. “If we find these [genetic] patterns are unique for fibromyalgia, it further and hopefully will forever legitimize in the minds of everyone that fibromyalgia is a real disease, that it’s a disease of the body’s immune system, and that consequently it’ll change how patients are diagnosed and treated, and hopefully how we may be able to cure or reverse the disease.”
Donna Gregory Burch was diagnosed with fibromyalgia in 2014 after several years of unexplained pain, fatigue and other symptoms. She was later diagnosed with chronic Lyme disease. Donna covers news, treatments, research and practical tips for living better with fibromyalgia and Lyme on her blog, FedUpwithFatigue.com . You can also find her on Facebook  and Twitter . Donna is an award-winning journalist whose work has appeared online and in newspapers and magazines throughout Virginia, Delaware and Pennsylvania. She lives in Delaware with her husband and their many fur babies.