Most laboratory tests are not very useful by themselves for diagnosing fibromyalgia. There is a blood test — called FM/a — that identifies markers produced by immune system blood cells in people with fibromyalgia. One study showed the test can also help distinguish fibromyalgia from other conditions that can have similar symptoms, such as rheumatoid arthritis or lupus.
Your doctor will often make a diagnosis after doing a physical exam and discussing your symptoms with you. The reason for this is that a diagnosis to large extent is based on the way you feel. For instance, even though your doctor may notice tender points during the physical exam, you still need to tell him or her about the pain you feel in those areas.
For fibromyalgia to be diagnosed, certain criteria usually have to be met. The most widely used criteria for diagnosis are:
- you either have severe pain in three to six different areas of your body, or you have milder pain in seven or more different areas
- your symptoms have stayed at a similar level for at least three months
- no other reason for your symptoms has been found
The FM/a Test is the first objective test to diagnose fibromyalgia using a simple blood test, with results usually available in a week — a fraction of the time and money patients typically spend seeking a diagnosis. The FM/a test is a multi-biomarker test based on immune system white blood chemokine and cytokine patterns; patients with fibromyalgia have a significantly dysregulated pattern regarding these proteins. Test results are based on a 1-100 scoring system, with fibromyalgia patients having scores higher than 50
The extent of the pain used to be assessed by applying gentle pressure to certain “tender points”, where any pain is likely to be at its worst. However, this is less common nowadays.
A new blood test for fibromyalgia is more accurate than previously thought and will not confuse the chronic pain disorder with other diseases such as lupus and rheumatoid arthritis, according to the physician who developed the test.
“We have not seen any overlap between the biomarkers in fibromyalgia and the immune system patterns of patients with rheumatoid arthritis or lupus. That really takes the air out of the sails of any naysayers that are out there,” said Bruce Gillis, MD, founder and CEO of EpicGenetics, a bioresearch company based in Santa Monica, CA.
EpicGenetics introduced the FM test in March, calling it the first definitive blood test for fibromyalgia, a poorly understood disorder that is characterized by deep tissue pain, fatigue, headaches, depression and lack of sleep. Test results are usually available in about a week.
Critics have said the same immune system biomarkers can be found in people with other illnesses, such as rheumatoid arthritis, making the blood test unreliable.
However, in new research involving over 300 patients with either fibromyalgia, lupus or rheumatoid arthritis, Gillis said only fibromyalgia patients were found to have below normal levels of chemokines and cytokines.
“They do not have the same immune system biomarkers. Not at all,” Gillis told National Pain Report. “The patterns we see in lupus and rheumatoid arthritis, we see this inflammatory process. But we don’t see the same biomarkers in fibromyalgia.”
Gillis said the research is still being finalized and he hopes to have it published in a peer-reviewed medical journal in the next few months.
When the FM test was first introduced, EpicGenetics said it was 93% accurate in diagnosing fibromyalgia. Gillis says the sensitivity of the test is now estimated at 99%, which is about the same as the test used to diagnose HIV.
The National Institutes of Health estimates that 5 million Americans suffer from fibromyalgia – and millions more around the world – but so far only a few hundred have signed up to take the FM test. Gillis says the $744 cost, which is generally not covered by health insurance, could be a barrier to many patients.
“A lot of people who’ve been diagnosed with fibromyalgia don’t work. And because they don’t work they don’t have the wherewithal to pay for a test. They don’t have health insurance,” said Gillis, adding that some insurers have paid for the test in worker compensation cases.
“When we first started, it cost us $12,500 to analyze a patient’s immune system parameters. So we’ve brought the price way, way down.”
Gillis hopes to bring the price of the FM test down further by licensing other labs to draw the blood and ship blood samples to EpicGenetics.
Regardless of the cost, fibromyalgia patients are excited that a simple test may finally be available to diagnose a disorder that their doctors and loved ones are often skeptical of. It takes three to five years for the average fibromyalgia patient to be diagnosed.
“Having a reliable blood marker will do more than validate us as patients. It will open a field of dreams and possibilities for researchers compassionate about defining this horrible disorder,” said Celeste Cooper, a fibromyalgia sufferer and patient advocate.