Fibromyalgia Treatment Trial Sparks Increase in Requests for EpicGenetics’ Diagnostic Test

Fibromyalgia Treatment Trial Sparks Increase in Requests for EpicGenetics’ Diagnostic Test
A 50 percent uptick in the past couple of months in applications for a diagnostic blood test called FM/a for fibromyalgia is largely due to a new clinical trial testing a tuberculosis vaccine for treating the condition, according to EpicGenetics, which developed the test. The collaborative Massachusetts General Hospital Phase 2 trial is investigating the use of a generic vaccine called BCG, globally used to prevent tubercolosis, to treat and reverse fibromyalgia. In September, the U.S. Food and Drug Administration approved the EpicGenetics-funded trial, which the company says has resulted in more requests for the FM/a test. "I regularly hear from patients who are thankful for a test that legitimizes their disease and saves them time and money of the traditional ‘rule out’ method,” Bruce Gillis, MD, EpicGenetics' CEO, said in a press release. "Patients are mobilizing because now, for the first time, there is hope. They have the chance of a treatment that does more than merely mask the symptoms. It actually addresses the disease of fibromyalgia.” The 2012 federal approval of FM/a, the first blood test for fibromyalgia, led California-based EpicGenetics to expand its research into disease treatment. This, in turn, led the company to Massachusetts General Hospital and Denise Louise Faustman, whose area of research is autoimmune diseases. She found that BCG stimulates a protein called tumor necrosis factor (TNF), which helps fight these disorders. Now that the FDA has approved the Phase 2 trial of BCG in fibromyalgia, 300 patients who test positive on the FM/a for the disease, will be enrolled. Half of the participants will get the vaccine, and the other half a placebo. Taking place at Massachusetts General, the study will include volunteers o
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