LOS ANGELES--(BUSINESS WIRE)--EpicGenetics, a privately held biomedical company dedicated to improving the diagnosis and treatment of fibromyalgia, today announced that the FM/a® Test for fibromyalgia is now available in Canada. With this announcement, Canadians who believe that they have fibromyalgia will be able to receive the first and only blood test available to accurately and definitively diagnose the disease.
The FM/a® Test, the first fibromyalgia blood test to comply with U.S. Food and Drug Administration standards, diagnoses fibromyalgia by identifying the presence of specific white blood cell abnormalities that have been documented to exist in these patients. The FM/a® Test accurately and objectively diagnoses this chronic disorder that afflicts millions of men, women and children.
With this announcement, patients will also now be eligible to participate in research efforts that will evaluate genetic markers for fibromyalgia. As part of this study, EpicGenetics will offer whole exome genetic surveys to FM/a® test-positive patients in a search for fibromyalgia-specific gene markers and mutations, analogous to the BRCA1/BRCA2 model for breast cancer. EpicGenetics’ associated CAMPAIGN 250 seeks to accomplish these gene surveys in up to 250,000 FM/a® test-positive individuals. The fees for these genomic surveys will be paid by EpicGenetics.
“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,” said Bruce Gillis, MD, CEO of EpicGenetics. “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.”
Initially launched in the United States in 2012, the FM/a® Test can be administered to patients in Canada, the United Kingdom, Europe, the Caribbean, South America, Central America, Australia, New Zealand, Mexico, Hong Kong and Turkey.
Patients who are suspected of having fibromyalgia need a licensed health-care practitioner to authorize their FM/a® Test. To learn more about the FM/a® Test, download the Physician Authorization Form or learn about the company’s recently-announced landmark clinical study efforts in fibromyalgia, visit www.FMTest.com or www.facebook.com/TheFMTest.
Fibromyalgia is a chronic disorder marked by a variety of symptoms that can include chronic diffuse pain, fatigue, sleep disturbances, muscle tenderness, headaches and depression, as well as problems with thinking and memory function. This disorder isn’t age, gender or ethnic specific.
Current treatment options for fibromyalgia are limited, offer only indirect and symptom-limited approaches, and primarily include anticonvulsants, opioids and antidepressants which help only some patients manage the disorder’s symptoms, though they do not treat the cause. Further, several of these treatments have potentially dangerous side effects.
About The FM/a® Test
The FM/a® Test is the first objective blood test for fibromyalgia that complies with U.S. Food and Drug Administration standards. It is a multi-biomarker-based test that analyzes immune system white blood cell production of critical chemokine and cytokine/protein patterns. These proteins demonstrate an abnormal pattern in fibromyalgia patients which the FM/a® Test can identify so it will correctly and objectively diagnose this medical illness. Results of the FM/a® Test are based upon a 1-100 scoring system, with fibromyalgia patients having scores higher than 50. The test has been clinically validated to diagnose fibromyalgia with a 93 per cent sensitivity.
The FM/a® Test is a result of research and clinical studies that were performed at the University of Illinois College of Medicine Chicago. It has been recognized by the American Association for Clinical Chemistry (AACC) for “Outstanding Research in Clinical and Diagnostic Immunology.” Peer-reviewed published medical studies have served as the basis of the FM/a® Test, based upon the testing of hundreds of patients.
The FM/a® Test is a Laboratory-Developed Test (LDT) that was developed — and is performed — in a United States CLIA certified and CAP accredited laboratory. The test fulfills the U.S. Food and Drug Administration regulation (21CFR 866.5700) for an immunological test system.
EpicGenetics, Inc. is a privately held biomedical company based in Los Angeles, California, that developed and manufactures the FM/a® Test. EpicGenetics is dedicated to improving the diagnosis and treatment of fibromyalgia by offering the first conclusive diagnostic test for fibromyalgia, and by investing in and developing further comprehensive clinical studies at leading medical research centres. More information is available at www.FMTest.com.