EpicGenetics, Universities Seek to Expand Fibromyalgia Genetic Markers Program, FM/a Test

EpicGenetics, Universities Seek to Expand Fibromyalgia Genetic Markers Program, FM/a Test

EpicGenetics is collaborating with the University of California, Los Angeles (UCLA) and the University of Illinois College of Medicine Chicago (UIC) to gather genetic information from fibromyalgia patients to improve the diagnosis capacity of its FM/a Test. This goal of this project is to detect fibromyalgia disease-specific genetic markers.

Based on the quantification of several blood biomarkers that have been associated with fibromyalgia, the FM/a Test can accurately and objectively diagnose this medical condition. It is an FDA-compliant blood test that has been clinically validated, presenting a 93% sensitivity to diagnose fibromyalgia.

“Since becoming available in 2012, the FM/a Test has successfully and objectively diagnosed patients with fibromyalgia in the U.S. and multiple other countries, thereby providing these patients with a definitive diagnosis and certainty about a medical condition that has often been misunderstood and erroneously denied as a legitimate medical disorder,” said Bruce Gillis, CEO of EpicGenetics, in a press release.

The company will offer genetic screens to patients who tested positive with the FM/a test. This will allow the identification of specific disease-related mutations and genetic markers, similar to the BRCA1/BRCA2 predictive genes for breast cancer.

EpicGenetics’ associated CAMPAIGN 250 seeks to accomplish genetic screens in up to 250,000 fibromyalgia patients. The costs associated with the genetic tests and for further research on the disease will be covered by EpicGenetics.

“There has been very little innovation over the past several decades to help patients better understand and manage their fibromyalgia,” said Frederick G. Behm, MD, head of pathology at the University of Illinois College of Medicine Chicago. “Patients with this disorder frequently experience pain and fatigue that prohibits them from being able to engage in their daily lives. These patients are seeking answers to basic questions about the cause and etiology of the disorder – and, as physicians, we are frustrated that our previously limited research in this field prevents us from being able to answer these questions.”

EpicGenetics also had established a protocol with Denise Faustman, MD, PhD, director of the Immunobiology Laboratory at Massachusetts General Hospital, in order to offer to all FM/a test-positive patients the opportunity to participate in a clinical trial on a potential vaccine for fibromyalgia.

“The Massachusetts General Hospital is announcing a new research effort on the application of the BCG vaccine, which will be directed at changing the biology of fibromyalgia as it concerns the foundational immune system discovery of the role particular cytokines have in fibromyalgia” Faustman said.

Patients who do not know if they have fibromyalgia and want to use the FM/a Test need to request an authorization from their licensed healthcare practitioner. The costs of the FM/a Test are covered by most insurance companies and Medicare.

9 comments

  1. Mary Carrazza says:

    This is very exciting news for Fibromyalgia sufferers and their families & friends. Actual research into the disease rather than a study which simple confirms what we already know – then to think that it may be possible to vaccinate against Fibromyalgia – the cost savings for governments world-wide would be enormous – and to prevent whole new generations of sufferers – that would be a remarkable achievement.
    Please don’t forget about us – the current bearers of this debilitating disease. Those of us living with Fibro daily are always hopeful of a cure. We look to research & studies like this in the hope that someone will produce the “magic pill” that will stop this disease in its tracks.

  2. Mary E Lee says:

    I’ve often thought there was a genetic component to FM. I believe my mother suffered from it also but there was no name for what she was experiencing so she called it “arthritis”. I was diagnosed 25 years ago. Today I see sings in my youngest daughter, age 50, of what I was experiencing at her age. At age 79, I don’t expect I’ll be around to see the results of this testing, but hopefully it will help others.

  3. Polly Nuschler says:

    “It is an FDA-compliant blood test that has been clinically validated, presenting a 93% sensitivity to diagnose fibromyalgia.”

    Does this mean that 7% of patients with FMS do NOT show a marker? 7% is a lot of people. The National Institutes of Health estimate that >5 million people living in America have fibromyalgia.

    350,000 people will NOT have this biomarker–now what? Will we now be told
    “You don’t have fibromyalgia. See you ARE making this up!”

    I am 68 years old and have been living with at times incapacitating pain, fatigue since I was 19 and had my serious bicycle accident–well no “accident” as I was struck head on by a car that had crossed the center line resulting in two vertebral fractures, broken ribs, broken jaw, face avulsion requiring multiple surgeries by a plastic surgeon, skull fracture and severe concussion.

    Even though I healed and returned to college and working full time, the pain and fatigue continued. I saw a neurosurgeon (hospitalized with multiple tests), orthopedic surgeon–more x-rays and appts. Two different neurologists, a gynecologist, had bone marrow biopsies (plural) muscle biopsies, nerve conduction tests, EEGs, EMGs, spinal taps,and on and on.

    I remember once being hospitalized, going back to my room in an elevator being wheeled by an aide and one of the neurologists I had seen got on. He looked at me, sneered and said “I see you got some fool to admit you.”

    (Back in the 1960s and 70s a person was hospitalized for testing–of course today most everything is done on an outpatient basis. We also have MRIs, PET scans that have replaced the old style x-rays, spinal myelograms,etc.)

    50 YEARS of being told “Nothing wrong with you.” I got two undergrad degrees and two post grad. I worked two to three jobs, married twice, now widowed and am STILL not taken seriously by most doctors although I was diagnosed by an internist for fibromyalgia.

    So if a doctor orders a test for specific biomarkers and the tests turn out negative? 350,000 folks will be told AGAIN that they don’t have a real disease?

    Could you have a rheumatologist or internist explain these tests further? Does a negative PROVE you DON’T have fibro? What false positives are seen? These are people’s entire lives we’re dealing with.

    I know that I could NOT handle one more negative test.

    • Janice says:

      Unfortunately, there are some that are misdiagnosed with Fibromyalgia when they have inflammatory arthritis, Low Vit D, Lupus, etc. There are doctors that are not doing their due diligence. Also, it is now estimated 10 million have Fibromyalgia as I believe the new 2010 criteria, updated several times since then is diagnosing more patients and more men. I think the 7% not testing positive were misdiagnosed as the criteria are not always being used properly and doctors are not running even the simplest of a test, like a Vit D level; low D causes pain.

      Go to MEpedia > Fibromyalgia to get the latest information all in one wiki.

    • Janice says:

      Another test doctors do not order is a Whole Body Bone Scan in Nuclear medicine. When you do not have a high SED nor come up positive on an RA test, doctors may not run this bone scan but you can come up positive on the bone scan without having a high SED nor test positive on the RA test. So instead of running the Whole Body Bone Scan, they will diagnose Fibromyalgia which may very well be wrong. Hydroxyqluorquine is prescribed for inflammatory arthritis. Also, 93% is very, very good as far as sensitivity.

    • Lori says:

      Sensitivity: A negative test can rule out the disease. 93% is a high sensitivity. Like Janice stated, a negative Fibromyalgia test probably means that a doctor did not do other tests like rule out low d (which causes pain and easily resolvable with D3 and K2) or run SED or Lupus and RA tests. But if they are all negative/normal, you would need to run a whole body bone scan for inflammatory arthritis because this disease does not always show a high SED. And even though RA is a type of inflammatory arthritis, not all inflammatory arthritis have a blood test and that is why you would need a whole body bone scan. Many doctors are afraid of having a patient go through a whole body bone scan because it is expensive and insurance companies do not like having to run tests when you can just get a Fibromyalgia diagnosis. But inflammatory arthritis has a medication ti prescribed and this medication, Plaquenil or hydroxychloroquine, will not work on Fibromyalgia. Fibromyalgia is an immune system disease and immune system diseases cause inflammation and inflammation cause pain. RA and Lupus are autoimmune diseases which also cause inflammation and pain but note they are autoimmune meaning the immune system is attacking the body, tissue, and organs where immune system mean the immune system is weakened and inflammation occurs. EpicGenetics is about to run a trial with patients receiving an old Tuberculosis vaccine to punch the immune system into working order stopping the inflammation which will stop the pain. They have apparently had success using the old TB vaccine Bacillus Calmette-Guerin (BCG) and the FDA is about to approve their large trial.

    • Lori says:

      Another interesting tidbit, Cymbalta only works on 6% of patients it is prescribed for. That always told me that those patients were misdiagnosed and have something all together. It is also interesting that psychiatrists are often the doctor to prescribe Cymbalta for “fibromyalgia” and I believe these are patients that are suffering depression which can cause pain, for some reason. So these patients that Cymbalta works on are not, imo, Fibro patients and they would probably be part of the 7% that do not test positive with this Fibro test.

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