Research about the new test was presented Sunday at the annual meeting of the American College of Rheumatology in San Diego.
EpicGenetics of Santa Monica, Calif., developed the test, called the FM/a test, says Bruce Gillis, MD, MPH. Gillis is the company’s CEO and an assistant professor of medicine and emergency medicine at the University of Illinois College of Medicine.
"It is objective, very accurate, and definitive," he says.
But the test’s high price tag -- $744 -- may keep its use limited for now, one expert says.
"Due to the cost and my lack of experience with this new test, I would initially use it in patients in whom I suspect as having fibromyalgia but lack some of the classic features, making the diagnosis more difficult," says Scott Zashin. Zashin is a clinical professor of medicine at the University of Texas Southwestern Medical School, Dallas.
Fibromyalgia causes widespread pain, tenderness, and stiffness in the muscles and connective tissues. The cause is not known. Six million people or more in the U.S. may have it, Gillis says. Usually doctors take a medical history and note symptoms. Often, it is a diagnosis made after excluding other diseases.
"The biggest problem is the skepticism that physicians have that don't believe that fibromyalgia is a real medical ailment," Gillis says. Often, he says, they label the patient as being depressed or being a hypochondriac.
"What our test does more than anything else is legitimize the diagnosis," Gillis says.
How the Fibro Blood Test Works
The test measures proteins in the body that lessen pain. "In patients with fibromyalgia, they cannot produce normal quantities of these proteins," Gillis says.
The test developers compared the blood test results in:
Ninety-three percent of the people who had fibromyalgia were identified correctly with the test, Gillis says, and 89% of those who did not were correctly identified.
Zashin, who is not involved with the company, says additional studies will be helpful. "If results could be verified, I would discuss the test with patients in whom the diagnosis of fibromyalgia is being considered to determine if they wanted to obtain the information provided by the testing,'' he says.
These findings were presented at a medical conference. They should be considered preliminary, as they have not yet undergone the "peer review" process, in which outside experts scrutinize the data prior to publication in a medical journal.