About Fibromyalgia

Fibromyalgia is a chronic disorder marked by a variety of symptoms that can include pain, fatigue, sleep disturbances, depression, and problems with thinking and memory function. This medical disorder is known to impact an estimated six percent of the population, and it isn’t age, gender or ethnically specific. However, due to a previous lack of diagnostic tools and a denial of the legitimate existence of fibromyalgia, many believe that this number may, in fact, be much larger. This prior lack of objective diagnostic tools has subjected FM sufferers to speculation and skepticism by friends, family and even those within the medical community.

Current treatment options for fibromyalgia are limited and primarily include anticonvulsants, opioids, and antidepressants which help some patients to temporarily manage the disorder’s symptoms but do not treat the cause of FM. Several of these drugs carry “Black Box Warnings” regarding their potentially dangerous side effects.

I’m ready.
How do I get the FM/a® Test?

If you can you answer yes to experiencing or having recently experienced at least four of these common fibromyalgia symptoms you are a good candidate for the FM/a® Test.

  • Chronic fatigue
  • Many painful or tender areas
  • Mental/brain fogginess
  • Poor sleep
  • Trouble concentrating
  • Frequent headaches
  • Joint aches

  • Leg cramps

  • Restless legs when you sleep

  • Anxiety/nervousness

  • Feeling depressed

  • Numbness or tingling

To get the FM/a® Test, your healthcare provider must provide authorization. If you do not have a physician, EpicGenetics can help you find a healthcare professional. We also require some basic information including your health insurance plan.

Objectively Better.

Fibromyalgia is no longer a medical disorder that is open to speculation and skepticism by friends, family and the medical community. The FM/a® Test looks directly at the biology of this disease, not just the symptoms, making the FM/a® Test the first, and currently only objective method to diagnose fibromyalgia via a simple blood test. The FM/a® Test results are usually available in about a week. The FM/a® Test is a multi-biomarker-based test, which analyzes your immune system’s white blood cell’s chemokine and cytokine patterns. Patients with fibromyalgia have an irregular pattern regarding these proteins. FM/a® Test results are based upon a 1-100 scoring system, with fibromyalgia patients having scores higher than 50. The sensitivity for the FM/a® Test is 93%.

DIAGNOSIS | CAUSE | TREATMENT

What is the FM/a® Test?

The FM/a® Test, is the first and currently only objective, FDA-compliant blood test for fibromyalgia. It’s simple and requires less than an ounce of blood. With a few exceptions, the FM/a® Test is available in most every state. Your blood specimen will be analyzed at our California laboratory.

I’M READY TO GET THE TEST
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Frequently asked questions

The FM/a® Test is a Laboratory-Developed Test (LDT) that was created — and is performed — in a CLIA certified laboratory. The test complies with FDA regulation (21CFR 866.5700) for a serum immunological test system and is covered by Medicare and most insurance companies.

If you have a personal medical background where you possess some or all of the recognized manifestations of fibromyalgia for several months or longer and have discussed your symptoms with your healthcare professional, you may decide you are a candidate for the FM/a® Test. This is currently the only blood test that can confirm the diagnosis of fibromyalgia in you. The specific traits of fibromyalgia include:

  • Muscle pain
  • Fatigue
  • Poor sleep
  • Joint pain
  • Headaches
  • Restless legs
  • Numbness
  • Tingling
  • Poor memory
  • Impaired mental concentration/Fibro fog/Brain fog
  • Leg cramps
  • Nervousness/anxiety
  • Depression

Those who have previously been diagnosed with fibromyalgia may want to have the test to ensure that your original diagnosis was accurate. Also, only recent FM/a® Test positive patients may choose to participate in Campaign 250 to see if they might have the genetic markers that led to their FM and/or opt to become a candidate for the vaccine, direct-therapy study which is being developed in cooperation with the Faustman Laboratory at the Massachusetts General Hospital.

Fibromyalgia strikes women and men, adults and children—it has no single or unique targets. If you have the chronic symptoms of fibromyalgia, you should consider yourself to be a potential test candidate. The test is meant to confirm the suspicion of you and/or your healthcare professionals that you have fibromyalgia or rule out fibromyalgia as the cause of your symptoms.

The FM/a® Test is drawn like any other blood test. It only takes minutes to obtain the small amount of blood (less than an ounce) that is required. Like any blood test, it should cause minimal discomfort. However, if you are on any medications at the time of the test, be sure you inform EpicGenetics as some prescription and over-the-counter medications and supplements may interfere with the FM/a® Test.

Growing numbers of patients are getting 100% insurance coverage for the cost of the FM/a® Test. If you would like assistance with coverage through your insurance provider, please contact our patient support team. Some patients may be responsible for an insurance deductible or co-insurance requirement.

You can have your blood drawn for the FM/a® Test at your healthcare provider’s office. An FM/a® Test kit with everything a medical professional needs to take the quick, simple blood test will be sent directly to the professional who will draw your blood. Your blood samples must be shipped overnight via our no-charge FedEx envelope to our laboratory in Los Angeles. Because the sample must be returned within 24 hours, your blood must be drawn between Monday and Thursday.

The results are sent per HIPAA rules and regulations in a confidential manner — via fax, and/or mail to your authorized healthcare practitioner. Test results are typically provided in seven–ten days, often sooner.

Before undergoing the test, patients must temporarily stop taking any medications and supplements that could block their immune system from revealing its fibromyalgia markers. These medications include those taken by prescription, without a prescription, or over-the-counter. Examples include steroid medications, anti-cancer medications, anti-transplant rejection medications, SINGULAIR® (montelukast sodium) and tumeric. Use of such drugs while taking the FM/a® Test could result in a false negative test, thereby rendering the test ineffective. Contact EpicGenetics about medications you are taking. While there are no other special pre-test considerations, you must obtain approval from your medical practitioner before stopping any medications you are currently taking.

Use of immunosuppressive medications should be discontinued two weeks before having the FM/a® Test but NEVER stop taking any medication without first getting written authorization from your healthcare provider.

Your blood test must arrive at the EpicGenetics laboratory within 24 hours, so, at no additional cost to you, the test specimen will be sent via Federal Express. In extreme weather conditions, sometimes Federal Express is unable to complete the transport of your specimen in that 24-hour window. Should that occur, thereby requiring a replacement specimen, EpicGenetics will cover 100% of the additional shipping cost (excluding travel, meal, and lodging costs if any).

The FM/a® Test requires extreme precision and familiarity with analyzing immunologic markers. EpicGenetics employs medical specialists, immunologists and the advanced scientific equipment required to perform your test. EpicGenetics does offer a license to other laboratories that meet our standards. EpicGenetics has filed for the exclusive U.S. and international patent rights to this test methodology.

The FM/a® Test is the first breakthrough in diagnosing FM. The Faustman Laboratory at the Massachusetts General Hospital has received a research gift to design a study to test the BCG vaccine as a potential remedy for this medical disorder. Learn more about Campaign 250.

Campaign 250 represents the largest and most ambitious study to investigate fibromyalgia’s genetic origins, as well as develop a treatment protocol addressing the underlying biology of the disease.

Under contract with researchers from both UCLA* and the University of Illinois College of Medicine Chicago, Campaign 250 will conduct Whole-Exome genetic testing on up to 250,000 patients who have received a positive FM/a® fibromyalgia diagnosis. All direct testing costs will be covered by EpicGenetics**. Based upon the findings of this testing and once treatment protocols have received regulatory and institutional approvals, FM/a® Test positive patients will be invited to participate in a fibromyalgia-specific vaccine clinical trial to reverse the biology of fibromyalgia. The vaccine trial will be conducted by Dr. Denise Faustman at the Massachusetts General Hospital/Harvard School of Medicine and will seek to alleviate fibromyalgia-related symptoms.

The goal is nothing short of ambitious—together we’re endeavoring to effectively change the understanding of fibromyalgia’s cause and develop a treatment that finally acts upon that cause, rather than simply masking the symptoms.

* UCLA has been contracted to sequence the exomes of research subjects
**A nominal $45 administration fee is required

Never guess again.

A quick, accurate and definitive test for fibromyalgia. No more years of unnecessary costs and time-consuming testing to rule out other diseases or be told it is “all in your head”. The FM/a® Test is now covered by Medicare and most insurance plans.

I’m ready to know for sure.
I’m ready for the FM/a® Test.

It’s time to be sure with a definitive diagnosis for fibromyalgia. The FM/a® Test is a simple two-step process. A positive test result can mean more than just knowing, as part of Campaign 250 it can help ensure you receive direct treatment and can help change the biology of the disease for more effective direct treatment in the future. Get started today with the two forms found below.