EpicGenetics’ FM/a Test for detecting fibromyalgia is now available in Canada.
FM/a was the first blood test for fibromyalgia to receive U.S. Federal Drug Administration approval— in 2012.
The test identifies white blood cell anomalies that are known to occur in those with the disease. It has a high accuracy rate, displaying 93% sensitivity in diagnosing fibromyalgia. This means the test identifies a person with the disease 93 percent of the time.
Patients whom the blood test diagnoses as having fibromyalgia will be able to take part in a genomic survey investigating genetic biomarkers for fibromyalgia, according to EpicGenetics. The hope is that the information will help scientists identify fibromyalgia-related mutations and genetic markers, similar to the BRCA1/BRCA2 genes that can predict breast cancer.
The company expects to include up to 250,000 patients in the survey. It will cover the costs.
“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 announced last month,” Dr. Bruce Gillis, EpicGenetics’ CEO, said in a news release. “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.”
The FM/a Test grew out of a collaboration between EpicGenetics and the University of Illinois College of Medicine Chicago. The American Association for Clinical Chemistry has recognized the test as an example of outstanding research in clinical and diagnostic immunology.
In addition to the United States and Canada, the FM/a Test is available in the United Kingdom, the Europe, the Caribbean, South America, Central America, Australia, New Zealand, Mexico, Hong Kong and Turkey.
Fibromyalgia is characterized by chronic pain and fatigue. These symptoms can cause sleep disturbances and anxiety, worsening the condition. The exact mechanisms underlying these symptoms have yet to be determined.