Major Breakthrough: A Highly Accurate Blood Test For Fibromyalgia

Although I’ve taken care of well over 2,000 fibromyalgia patients since first opening WholeHealth Chicago in 1995 (and also written a successful book on the subject), I was always troubled by two questions.

First, exactly what is fibromyalgia? How can there be a condition that’s severe enough to be disabling, manifesting as widespread muscle pain, profound fatigue, poor sleep, headaches, and a half dozen other symptoms and yet offers doctors no clue as to what’s going on, no positive diagnostic test results?

Second, why are all tests for fibro negative? Symptomatic patients visiting doctors for years were endlessly told, “Your tests are normal.” And when, years later, a person with these symptoms first heard the word fibromyalgia, she also learned it was called a “diagnosis of exclusion.”

This means you get tested for all possibilities, from autoimmune disorders to chronic Lyme disease, and when no positive test results come back, by excluding everything else you are told you have fibromyalgia. And in the saddest of circumstances no shortage of empathy-free doctors may simply dismiss you as neurotic or lazy.

If you did find a physician familiar with fibro, when you were diagnosed you likely received one of the FDA-approved medications (duloxetine/Cymbalta, milnacipran/Savella, pregabalin/Lyrica), which after years of use both patients and physicians agree are unevenly effective.

You may also have received some off-label meds, like a muscle relaxant, an antidepressant, or a prescription for pain meds. You probably felt a little better, but nothing really dramatic occurred.

And all this time—decades for some of you–both you and your physician were wondering, “What is fibromyalgia? What exactly is being treated here with all these perpetually negative tests?”

FM/a: an astonishingly accurate blood test for fibro
Today’s truly major news is the availability of a blood test that so far is astonishingly accurate in the specific diagnosis of fibromyalgia. It’s called FM/a and was developed at my own alma mater, the University of Illinois College of Medicine at Chicago.

Using a small amount of blood, the test seeks out the genetic pattern of two chemicals, called cytokines and chemokines, that your body produces under a variety of circumstances. Cytokines have gotten a lot of publicity during the Covid-19 pandemic because many of the serious complications during infection with the virus are triggered by the dramatically named cytokine storm.

Cytokines and chemokines are pro-inflammatory, meaning they trigger widespread inflammation and possibly pain. One of the drugs used during Covid-19 cytokine storms, dexamethasone, is a steroid and a very powerful anti-inflammatory agent.

With fibro, the cytokine/chemokine system is dysregulated, which means it isn’t working correctly. People with fibromyalgia are genetically susceptible to this dysregulation, which may explain why fibro can run in families. The genetic susceptibility doesn’t always actually lead to fibro, however. Usually some sort of triggering event is required, like a physical or emotional trauma, surgery, or an infection.

The Covid-19 pandemic is sparking a lot of new fibromyalgia cases and worsening existing ones. In addition to the emotional anxiety associated with Covid-19, it’s possible that the new fibromyalgia diagnoses are occurring because these patients may in fact have an otherwise mild case of Covid-19 and this is the way it’s manifesting itself.

Dysregulation triggers sensitization
The dysregulation of the cytokine/chemokine system in turn triggers a situation called central sensitization, best described as a dramatically increased sensitivity to a variety of stimuli that end with your brain receiving the message “PAIN!” Hugged by your child? PAIN! Going through your PMS days? PAIN! Pressure of your mattress during sleep? PAIN!

The new FM/a test looks for evidence of this cytokine/chemokine dysregulation. If your test result is positive, you have a definitive diagnosis of fibromyalgia. If someone says, “There’s no such thing as fibromyalgia,” you can either show them your test result or just give them a good slap across the face. (Or do both.)

Several important points
Although the FM/a test is covered by most commercial insurance plans and Medicare, it’s quite expensive ($800), so before you have it your doctor will need to register with the company and complete a short application (available here on the FM/a website) and fax it to the lab (EpicGenetics). This will start the process of getting prior authorization from your insurer. (There’s also a patient form for you to complete.)

You will then receive notification to go to a blood drawing station near your home, where your blood will be taken and sent to EpicGenetics. You’ll get your results back in about a month.

Because of the relationship between Covid-19 infections and cytokines, EpicGenetics is also running an antibody test for SARS-CoV-2 (which causes Covid-19) at no additional cost. Some early evidence indicates that because of this cytokine dysregulation, people who test positive for fibro on the FM/a test actually have a lower incidence of cytokine storm complications compared to the general population of those with Covid-19. The company is trying to collect more data about this.

A research project for fibro treatment
Finally, if you test positive for fibromyalgia through the FM/a test, you’ll be invited to participate in a research project. It will test the effect of a vaccine that’s been around for 100 years (yes, really! It was first administered in 1921) whose potential therapeutic use for fibromyalgia has only recently been appreciated.

Bacillus Calmette-Guerin (BCG) is a vaccine primarily used against tuberculosis (TB) and is mainly administered to infants and children in countries where TB rates are high. It’s rarely used here in the US because of our very low incidence of childhood TB.

I myself received the BCG vaccine in medical school because there was still a lot of TB circulating and we had clinical rotations in TB sanitariums. Because BCG is known to regulate cytokine systems, preliminary studies using BCG as a treatment for fibromyalgia have been very encouraging.

If you choose to volunteer for the BCG trial, you’ll receive either one annual BCG injection or one placebo injection for three years. (You’ll also be asked to maintain a symptom diary.) This is a classic example of a double-blind study where neither the patient nor the physician supervising the study knows which injection you’re receiving. When the test period is over, the researchers will “unblind” the study to determine if those receiving BCG injections did better than those receiving the placebo. You can read about the clinical trial here.

This is all pretty exciting for people with fibromyalgia. WholeHealth Chicago patients can simply ask their practitioner to order the test for them and then review the results together.

Out-of-town patients are welcome to set up phone consultations with WHC practitioners, who can order the test for them. Alternatively, just ask your family physician, nurse practitioner, or chiropractor to order the test for you.

Keep in mind that if you’ve previously been diagnosed with fibromyalgia and your test comes back negative, you’ll need to be working with a practitioner familiar with other causes of your chronic pain and fatigue.

In the meantime, go to the FM/a website, watch the videos, and learn about this major breakthrough yourself.

Be well,
David Edelberg, MD

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2 comments on “Major Breakthrough: A Highly Accurate Blood Test For Fibromyalgia
  1. Evelyn Medina says:

    Wow, this has opened a new chapter for me.

    I hope that this blood test will finally detect if these pains are caused by fibromyalgia.

    Can’t wait to get started. Thank you for sharing this good news.

  2. Jacob says:

    Dear Dr. Edelberg,

    Thank you for the informative article.

    Besides for the BCG vaccine, are there any other promising treatments (supplements/medications etc) for the dysregulation of the cytokine/chemokine system seen in Fibromyalgia?

    Thank you,
    Jacob

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