The story below on the FM/a fibromyalgia test first appeared on NationalPainReport.com. It is being republished here with permission from the editor. (Note: I have no financial interest in EpicGenetics or the FM/a fibromyalgia test.)
Updated 2/22/22: StatNews.com published an investigative article questioning how the FM/a test was developed and its accuracy.
Do you have a family member, friend or physician who doubts you have fibromyalgia? Well, there’s a little-known test you may not have heard of that could finally prove you’re really sick.
In 2013, Los Angeles-based biomedical company EpicGenetics made international headlines when it introduced FM/a, the first ever fibromyalgia test.
While FM/a hasn’t caught on in most doctors’ offices, more insurance companies are now paying for the test. FM/a is covered by most Medicare plans. Private insurers, such as Blue Cross Blue Shield, UnitedHealthcare and Aetna, also are starting to pay for the test on a case-by-case basis.
The test’s steep price tag – $794 – has been a deterrent for patients, many of whom are already living on fixed incomes because they’re unable to work due to poor health.
EpicGenetics is trying to make it easier for patients to afford the test by providing free assistance with insurance processing. The company’s insurance processing department contacts insurance companies on the patients’ behalf to find out if the test is covered and what the cost would be to the patient.
(A six-installment, no interest payment plan is available for people who are uninsured or whose insurance won’t cover the test.)
Dr. Bruce Gillis, EpicGenetics’ CEO, says the No. 1 reason patients get the test is to prove to family members and others that they are really sick.
He believes physician bias is the main reason why the test is not more widely used.
“The majority of physicians do not believe that fibromyalgia is real, so they haven’t kept up with the advances that have occurred, including reading something as simple as WebMD, which tells everyone the test exists,” he says. “In under 10 seconds, a Google search reveals the test.”
Many physicians don’t consider fibromyalgia to be a disease; they believe it’s a collection of symptoms and lump it into the “syndrome” category.
And then there’s another group of physicians who don’t believe fibromyalgia exists at all. Patients are routinely told they’re “depressed” or “getting older” – or worst still, the pain, fatigue, brain fog and other debilitating symptoms are all in their heads.
The legitimacy of fibromyalgia has been complicated for decades because of the lack of a diagnostic test to prove its existence. It’s typically a diagnosis of exclusion – meaning illnesses with similar symptoms have been ruled out through extensive (i.e. often expensive) medical testing.
According to EpicGenetics, patients can spend between $10,000 and $42,500 on diagnostic tests leading up to their fibromyalgia diagnosis. That’s a lot of money, and that’s another reason why physicians haven’t embraced the FM/a test, Gillis says.
“Many rheumatologists prefer to offer patients rule-out tests, which they can perform in their office labs, thereby making for a financial incentive to follow that route,” he explains.
How the FM/a fibromyalgia test works
A licensed healthcare professional must order the test for the patient. The test requires a simple blood draw, and results are available within five to seven days. It has a sensitivity of 93 percent – equivalent to the blood test for HIV. (No test has a sensitivity of 100 percent.)
Gillis admits he used to be one of those physicians who doubted the existence of fibromyalgia, but the results of EpicGenetics’ research studies have made him a believer.
EpicGenetics focuses on developing diagnostic tests where none currently exist. When Gillis was asked to look at fibromyalgia, he and researchers from the University of Illinois College of Medicine in Chicago theorized that fibromyalgia’s mishmash of symptoms might be caused by a malfunctioning immune system.
The first study looked at a series of immune system biomarkers in 17 patients with fibromyalgia and 17 healthy people, and the results were striking. Researchers found several biomarker abnormalities among the fibromyalgia patients, leading Gillis to conclude fibro symptoms are somehow associated with a suppressed immune system.
“We believe [the term] fibromyalgia is a misnomer,” he 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 product 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.”
The test focuses on four chemokines and cytokines found at reduced levels in fibromyalgia patients, according to Gillis.
Two subsequent studies, one of which compared fibromyalgia patients to those with rheumatoid arthritis and lupus, supported the results of the initial study, Gillis says.
“These people [with fibromyalgia] have immune system dysfunction,” he says. “These people are really sick. It’s not in their head. … Why aren’t the drug companies knocking down our door to develop a treatment?”
EpicGenetics’ research and the FM/a test aren’t without critics. The American College of Rheumatology does not recognize FM/a as a valid test.
Fibromyalgia expert Dr. Daniel Clauw has said EpicGenetics’ studies contradict other research, which has shown normal or elevated cytokine levels in fibromyalgia sufferers. Researcher and rheumatologist Dr. Fred Wolfe called one of EpicGenetics’ studies “junk science,” saying it didn’t meet minimal scientific standards.
But in 2012, the American Association for Clinical Chemistry gave EpicGenetics an award for outstanding research in clinical and diagnostic immunology for its fibromyalgia research, says Gillis.
EpicGenetics isn’t letting the doubters keep them from moving forward. In the future, Gillis said the company would like to study the DNA of fibromyalgia sufferers to see if a genetic component can be identified. Proceeds from the FM/a test are being funneled toward that effort.
Click here for more information on the FM/a fibromyalgia test.
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