New research results have upheld the validity of a blood test that can diagnose fibromyalgia, according to the chief executive of a Santa Monica-based company that began offering the test earlier this year.
“We’ve proven that fibromyalgia can be diagnosed unequivocally through this test, a test that remains highly sensitive and specific,” said Bruce Gillis, MD, founder and CEO of EpicGenetics.
The FM test looks for protein molecules in the blood called chemokines and cytokines, which are produced by white blood cells. Fibromyalgia patients have fewer chemokines and cytokines in their blood, according to Gillis, and have weaker immune systems than healthy patients.
But critics said the blood test was unreliable because the same immune system biomarkers can be found in people with other illnesses, such as rheumatoid arthritis.
The new research, which was conducted by EpicGenetics, involved nearly 500 people. The blood test was given to 160 fibromyalgia patients, 100 lupus patients, 98 patients with rheumatoid arthritis and 119 healthy people who served as a control group.
Over 93% of the patients who had fibromyalgia were correctly identified by the blood test, according to Gillis, and over 89% of those who did not have fibromyalgia were correctly identified.
“What we found is that the biomarkers do not occur in other rheumatologic diseases, it’s only in fibromyalgia,” Gillis told National Pain Report. “I cannot tell you if these biomarkers are the cause of fibromyalgia or if it’s a byproduct from fibromyalgia. We don’t know that yet. But these findings are the first objective methods to prove a patient has fibromyalgia.”
The National Institutes of Health estimates that 5 million Americans suffer from fibromyalgia, a poorly understood disorder characterized by chronic deep tissue pain, fatigue, headaches, depression and lack of sleep. There is no known cure and many patients go for years before being diagnosed – often dealing with skeptical doctors and family members who doubt the severity of their pain.
“The test does two things. It doesn’t merely give you the diagnosis of fibromyalgia, it legitimizes the diagnosis of fibromyalgia,” says Gillis.
“It proves it’s a real disease. It’s not a bogus affliction of neurotic, crazy, hypochondriacally people. They really are sick. There’s something wrong in their immune system processing.”
Much of the new research was conducted Daniel Wallace, MD, a rheumatologist at the Cedars-Sinai Medical Center in Los Angeles and a professor of rheumatology at UCLA. Wallace, who has written a number of books on fibromyalgia and other autoimmune diseases, is on EpicGentics scientific advisory board. He could not be reached for comment on this story.
Dr. Gillis says the research results were well received when he presented them last month at the annual meeting of the American College of Rheumatology in San Diego.
“It now I think eliminates the last criticisms by any naysayers regarding the test. It says that we listened to their criticism and we approached it in a direct fashion to answer the question,” Gillis said.
But some critics remain.
“I wish Dr. Gillis well in his quest to establish even a shred of scientific credibility for his test, which has been vitiated by what Sir William Osler referred to as ‘the corroding influence of mammon,’” wrote John Quintner, MD, a prominent rheumatologist in Australia, in an email to National Pain Report.
Quintner has been skeptical of previous research conducted by EpicGentics. So has Fred Wolfe, MD, a rheumatologist who has called the fibromyalgia blood test “junk science.”
Critics are waiting for the new research to be published in a peer reviewed medical journal. Gillis says a report on the new study is still being written and he hopes to get it published in the next few months in a “highly regarded, well respected, peer reviewed journal.”
The FM test kit costs $744 and is not covered by most insurance companies. Blood samples are shipped to an EpicGenetics laboratory for testing and results are usually available in about a week.