For four years, EpicGenetics has been selling its diagnostic for fibromyalgia in the U.S. Now it can list Canada among its international markets for the test.
The company says approval and launch in Canada will help it push forward with an ambitious R&D program that is trying to decipher the underlying genetic basis for the chronic and painful condition, which affects millions of people worldwide.
The Santa Monica, California, company made waves when its FM/a blood test for fibromyalgia secured a CLIA certification and became the first test available for fibromyalgia, which often goes undiagnosed because its symptoms can be so diverse. Aside from pain it can be accompanied by fatigue, sleep disturbances, muscle tenderness, headaches and depression, as well as problems with thinking and memory function.
Last month, EpicGenetics teamed up with the University of California, Los Angeles, and the University of Illinois Chicago College of Medicine to offer genetic screening tests to people whose FM/a test results are positive in an effort to identify the gene sequences that might make people susceptible to developing fibromyalgia. The research effort is aiming to get genetic screens for 250,000 fibromyalgia patients and trying to kick-start research into new therapies for the disorder.
At the moment, there are just three FDA-approved drugs—Pfizer's Lyrica (pregabalin), Eli Lilly's Cymbalta (duloxetine) and Allergan's Savella (milnacipran)—which have been shown to reduce pain but are only effective in some patients and have side effects. Many patients rely on drugs and other approaches such as massage and gentle exercise to treat symptoms.
"There has been tremendous response and interest from Canadians in receiving an accurate fibromyalgia diagnosis with the FM/a test and in participating in our landmark clinical study efforts," said EpicGenetics CEO Bruce Gillis, M.D. "We are excited to announce that we can now accommodate these patients and finally provide them with certainty about a commonly misunderstood and misdiagnosed disorder."