I recently wrote about a new blood test for Fibromyalgia that uses genetic profiling to help pinpoint the best treatment options for Fibro.
This article is not about that test.
This article is about an older blood test I’d heard about but knew nothing of.
If you have Fibro, you have probably heard of this test but know little about it.
(If you have taken it, please let us know your experience in the comments section.)
The thing is, when I started digging, I couldn’t stop.
There’s a lot of controversy over this test.
So what is the FM/a blood test?
And why is it so controversial?
I explain both below, plus give you the details on its cost, its creator, and everything else you need to know.
What is the FM/a blood test?
The FM/a blood test is a diagnostic screening tool for people who think they have Fibromyalgia and want a conclusive answer as to whether or not they have it.
The test has been advertised as “The first and only blood test to accurately and definitively diagnose the disease.”
So what does the FM/a test do to diagnose?
The FM/a test measures cytokines in the blood. Research shows that people with Fibromyalgia tend to have lower levels of cytokines than folks without Fibro. They may display “unique immunologic patterns,” as the study puts it.
Cytokines are proteins that oversee other cells’ growth in the body’s immune system. These proteins are the green light for the immune system to go ahead and do its work. They essentially control inflammation in the body.
Does the FM/a test work?
It depends on which doctor you ask. Many physicians feel that the FM/a test isn’t as “definitive” for diagnosing Fibromyalgia as the company behind the test – EpicGenetics – makes it out to be.
This is because very few studies have been done to prove its accuracy. Only one study was completed in 2012 before the FM/a test became available to the public the following year.
And even in the study, the authors explained that the data they collected was “exploratory and provided preliminary information.”
Furthermore, people with other chronic conditions (like arthritis and lupus) may also present similar cytokine abnormalities, and the test may not distinguish between them.
According to Uma Sharma, chief scientific officer at the research firm MMS Holdings, these abnormal cytokine patterns are not all that unique to Fibro.
That opens the door for a possible incorrect diagnosis and lots of (extra) frustration on the patient’s part.
A follow-up paper published in 2015 found that even some people without Fibromyalgia also displayed this abnormally low level of cytokines. They too could have this “unique immunologic pattern.”
Who created the FM/a blood test?
EpicGenetics is the company behind the FM/a blood test. The spearheader behind EpicGenetics is Dr. Bruce Gillis.
Initially, Dr. Gillis was a self-proclaimed “Fibro-skeptic,” until he and a team at the University of Illinois College of Medicine discovered data from a pilot study that shocked them.
What they found was that people with Fibro had “unequivocal immune system abnormalities.”
How much is an FM/a test?
You can expect to pay $1,080 for the FM/a test if you’re paying out of pocket.
Does Medicare cover the FM/a test?
No, Medicare does not currently cover the cost of the FM/a blood test.
This is because in 2021 the Centers for Medicaid and Medicare Services (CMS) stopped Medicare payments due to “credible allegations of fraud.” Rather, they deem the test’s accuracy flawed and medically unnecessary.
Where to get the FM/a test?
You might have difficulty securing your own FM/a test at the moment because Medicare no longer covers it and all websites related to EpicGenetics appear defunct.
Before the controversy issues, you’d be able to apply for the test (typically with the referral of your doctor, but from comments I’ve read in Fibro boards it seems you could have also applied directly yourself.)
Once approved for the test, the kit would be sent to your house and you’d do it yourself. How, I’m not so sure.
You can see this (likely unusable now) EpicGenetics referral form – but I don’t recommend you print it out and take it to your doctor.
How would I qualify for the FM/a test?
As of 2021, for patients to qualify for the FM/a blood test, they would need to demonstrate at least 4 of the typical symptoms of Fibro:
- chronic fatigue
- tender/painful areas all over
- brain fog
- poor sleep
- trouble concentrating
- frequent headaches
- frequent joint aches
- leg cramps
- restless leg syndrome
- anxiety and nervousness
- feeling depressed
- numbness
- tingling
Totally doable, check.
You can also check for Fibro symptoms with these three simple steps.
Does the FM/a test get reported to my doctor?
The results from the FM/a test are sent directly to you.
It’s up to you if you want to show the information to your doc.
The controversy over the FM/a blood test for Fibro
EpicGenetic’s FM/a test is shrouded in controversy in the medical community. The company is even being sued by The Center for Science in the Public Interest (CSPI), a non-profit watchdog and consumer advocacy group. The suit claims that EpicGenetics inflated the test’s accuracy.
For example, EpicGenetics claims their FM/a test is “99 percent accurate.” Yet EpicGenetic’s own study on the test says it can produce a false negative 7% of the time and false positive almost a third of the time in people with lupus or rheumatoid arthritis.
Abrupt pulling of clinical trial funding, leaving patients seeking treatment hanging, and not enough evidence in the studies to support that the test is completely accurate are some of EpicGenetic’s (and therefore the blood test’s) big-ticket issues.
I’m not a doctor, but I am genuinely curious about this test. Here’s what I learned:
Dr. Gillis abruptly dropped out of a big research project
In 2017, Dr. Gillis pledged millions of dollars to help fund a treatment trial at for Fibromyalgia patients. The program got FDA approval in 2018, however soon after Dr. Gillis stopped his pledge payments.
EpicGenetics left a lot of patients in the dark
Many patients were told that if they received a positive result on their FM/a test, they’d be able to volunteer for a treatment clinical trial at Massachusetts General Hospital.
Only the trial never happened. No patients who wanted to sign up and try something, anything to help got it.
God, that must’ve been depressing for them. I feel for them. Don’t you?
Most doctors don’t yet see enough supporting evidence
Many doctors agree that because low cytokine levels can be found in people with other chronic conditions, there isn’t yet strong enough evidence to support a true diagnosis for Fibromyalgia.
Your takeaway
So let’s recap:
What is the FM/a blood test? It is (was?) an at-home test you could take that measures your blood’s cytokine levels and “unique immunologic pattern”.
The results get sent back to you and give you a false or positive Fibromyalgia result.
Out of pocket, the test costs $1,080. Medicare suspended coverage for the test in 2021.
While the test could provide some peace of mind, there’s plenty of controversy surrounding the test, the company behind it, and the man spearheading the company, Dr. Bruce Gillis.
If you think you have Fibromyalgia, a good place to start is this post.
6 replies on “What Is The FM/a Blood Test? (And The Controversy It’s Causing?)”
If nothing else, Dr. Gillis is a smart marketer. I’ve been involved in marketing nutritional supplements for a long time and never thought of saying “no prescription needed” as if it was an act of generosity by the seller to not require a prescription. I am hoping that this supplement works for people but I am highly skeptical of this doctor. I had his original test done probably a decade ago (tested positive, no surprise, I knew I had it due to symptoms), and never heard back from him although I was told I would be eligible for a vaccine against fibromyalgia and that’s why I took his test. I don’t want to take hope away from anyone because it is a very important factor in healing, but I also hate to see people wasting more money on more false claims.
Hi Bunny,
Your story echoes similarly to others I’ve read. How disappointing it must have been to take the test and never hear back. It’s also so true that hope is very important when healing. But often what you gain in hope is sliced and diced when something like that happens to you.
Dr Gillis is now selling his treatment directly.
https://imbxx.com/
Any thoughts?
Hi Cary,
I’ll be sure to take a look.
– Emily
I have had the Fm/a blood test twice years apart and both came back positive for fibromyalgia. I went 3 years seeking a diagnosis with countless useless blood tests to test for everything else BUT fibromyalgia. The doctors out there that should know about fibromyalgia just don’t. They either slap the label on because they can’t figure out what’s going on or there are the drs who are complete skeptics. I’ve been to numerous Rheumatologists and neurologists in hopes for help. I didn’t receive any. I did my own research and seeking help. I think that Dr. Gillis should get more praise for what he has done for the fibro community and I think there’s a lot of doctors who don’t want to do that (maybe it’s the God like complex that doesn’t want to give credit). But Dr. Gillis has created a blood test to rule in Fibro or not. 1 test not the countless test to rule everything else out. Is it labs who want the money for the countless blood tests? Is it pharmaceutical companies who want to give out community rehashed medications and slap Fibro meds on it and claim it works for fibromyalgia? It’s a complete joke. So let’s give the man the credit he’s due. I was also in the recent successful Fibro study for IMBXX. Again thanks to Dr. Gillis for researching and developing this and not making it a prescription so that all have access to it. I’m sure pharmaceutical companies will try to disparage this because they can’t make money off of it. The Fibro community is strong and we have very loud voices. Maybe because we’ve had to scream to get someone to listen to us. So I’m screaming thank you Dr. Bruce Gillis for give us help and hope again!
That’s wonderful that you’ve had positive experiences with the FM/a test and Dr. Gillis’ work. As you said, keep being loud about it so others can hear and keep up hope!
And I hear you when you say pharmaceuticals “hand out” meds for Fibro – ones that they barely help and serve up more side effects and benefits. At least, that’s my experience.
Thanks for chiming in, Colleen.