07.02.2019

Researchers may have found genetic marker for fibromyalgia

This article was originally published on Prohealth.com and is being reprinted here with permission from the editor.

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.

Dr. Bruce Gillis

“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.

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.

(Read more: More insurance companies now paying for FM/a fibromyalgia test)

Previous EpicGenetics studies showed fibromyalgia patients have reduced levels of four specific chemokines and cytokines, signifying suppression of the immune system.

“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.

(Read more: Century-old vaccine gives new home to fibromyalgia community)

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.

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.”

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.

“We are cautiously optimistic that we are on the throes of a breakthrough in better understanding fibromyalgia. 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.”

Dr. Bruce Gillis, CEO, EpicGenetics

Now it’s your turn: Are you excited by this potential new finding? Share your opinion below in the comments section!

Researchers may have found genetic marker for fibromyalgia | Fed Up with Fatigue

Comments

  1. MAXINE says

    I was diagnosed with Fibromyalgia in 2000 after a year of intensive testing for everything known to the medical world. I was super sensitive to all chemicals and gained weight at the rate of 1 lb per day. I always knew that the condition I had was not muscular. I also knew that is was not related to arthritis. My symptoms led me to believe that what I was suffering from was neurological somehow, but I am not a medical person so I was relying on how I knew my own body. I developed my own regimen of care beginning with regular physical exercise; completing reorganizing my nutritional regimen and controlling the amount of stress that I allowed into my life.I am super interested in this finding and would like to know more about the research that continues. I have been able to live an active, productive life without relying on drugs of any kind. Of course age has and is taking it’s toll, but I believe that my ability to listen to my own body has benefit and may be helpful to your study and to others who are battling this ???

  2. It’s more than annoying that I found this out from a blog rather than Dr. Gillis about the status of the FM vaccine trial. An unknown number of us who tested positive years ago have been awaiting the trial and have received virtually no information from Gillis or EpicGenetics over the years. The way the clinical trial was presented to me before I took the blood test was that it would let one into the trial automatically. Reading the proposed trial on the Federal trials website, it appears that only a small number of people will actually receive the vaccine and, even if successful, non participants won’t be eligible to take the vaccine for three years, even assuming the FDA instantly approves it when the study ends. This study has ignored the needs of the fibro community it ostensible seeks to help.

    • Agreed! No excuse for radio silence on the status of the trial when you have lured those of us seeking a solution. I was also told I would unequivocally get the vaccine. I knew that was too good to be true. In addition, my insurance company did not cover the test. So far, I’m not impressed with how this trial is being conducted. But still holding out hope…..

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