LOS ANGELES--(BUSINESS WIRE)--On the heels of Veterans Day, EpicGenetics, a privately held biomedical company dedicated to improving the diagnosis and treatment of fibromyalgia, reports that the FM/a® Test allows Gulf War veterans to have objective proof of their fibromyalgia. A positive test result can subsequently support and objectify an application for a VA-related disability. The FM/a® Test is the first and only objective, FDA-compliant blood test to provide a definitive diagnosis for fibromyalgia. Moreover, a positive FM/a® Test result could enable veterans to qualify for a planned clinical trial evaluating whether treatment with the Bacillus Calmette-Guérin (BCG) vaccine could potentially reverse the biology of their fibromyalgia.
The U.S. Department of Veterans Affairs (VA) officially acknowledges fibromyalgia as a recognized medical condition warranting disability coverage for Gulf War veterans. According to supporting research, 1990-1991 Gulf War deployment is associated with an increased risk for fibromyalgia and Chronic Fatigue Syndrome.i The FM/a® Test is a recognized diagnostic tool that provides an objective diagnosis of fibromyalgia for Gulf War veterans with this disorder who are seeking to qualify for disability coverage. Additionally, the FM/a® Test is now covered for veterans by CHAMPVA insurance, as well as Medicare and most PPO insurance plans.
“We are proud that the FM/a® Test can play a role in helping our veterans not only accurately and definitively diagnose their fibromyalgia, but also enable Gulf War veterans to seek appropriate disability reimbursement for the disorder,” said Bruce Gillis, M.D., CEO of EpicGenetics. “Traditionally, fibromyalgia has only been diagnosed through a process of ruling out all other potential conditions, a costly and time-intensive process that has made it notoriously difficult to prove the presence of fibromyalgia for disability claims. Now, veterans who are believed to have fibromyalgia can confirm their diagnosis and support their claim with this simple, objective blood test.”
The FM/a® Test is an FDA-compliant blood test that 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.
“Importantly, all veterans who receive a positive test result can also potentially qualify for a planned clinical trial to evaluate a direct treatment approach for the disorder,” said Dr. Gillis. “We are hopeful that the initiation and subsequent findings of this clinical trial will result in the identification of an effective, direct treatment for fibromyalgia. With no effective treatment options currently available, these advancements have the potential to help millions of Americans, including thousands of our veterans, who suffer every day from common fibromyalgia symptoms such as chronic pain, fatigue and depression.”
The planned clinical trial will take place at a leading U.S. medical research center and will test the potential of the BCG vaccine to effectively treat fibromyalgia, actually reversing the biology of the disorder. This is unlike today’s fibromyalgia therapies, which are limited to addressing the symptoms of fibromyalgia. FM/a® test-positive patients will be offered an opportunity to participate in this vaccine trial once the study protocols have received the required institutional and regulatory approvals. Based on the anticipated effectiveness of the planned vaccine trial, a direct treatment pathway would become available and eliminate the need for symptom-limited medications and the use of opioids/narcotics for the treatment of fibromyalgia.
The cost of the FM/a® Test is covered by CHAMPVA insurance, as well as Medicare and most PPO insurance plans. Patients who are suspected of having fibromyalgia only need a licensed health care practitioner to authorize their FM/a® Test.
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 is known to impact an estimated 6 percent of the population,ii and it isn’t age, gender or ethnic specific. However, due to a previous lack of diagnostic tools and a common denial of the legitimate existence of fibromyalgia, many believe that this number may in fact be much larger.
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 carry “Black Box Warnings” regarding their potentially dangerous side effects.
About The FM/a® Test
The FM/a® Test is the first FDA-compliant, objective blood test to diagnose fibromyalgia. 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.iii,iv 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 percent 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 CLIA certified and CAP accredited laboratory. The test fulfills the FDA 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 centers. More information is available at www.FMTest.com.
i Elsen SA, Kang HG, Murphy FM, et al. Gulf War veterans'
health: medical evaluation of a U.S. cohort. Ann Intern Med. 2005 Jun
ii About Fibromyalgia: Prevalence. National Fibromyalgia & Chronic Pain Association. http://www.fmcpaware.org/fibromyalgia/prevalence.html.
iii Behm FG, Gavin IM, Karpenko O, et al. Unique immunologic patterns in fibromyalgia. BMC Clinical Pathology 2012, 12:25 http://www.biomedcentral.com/1472-6890/12/25.
iv Wallace D, Gavin IM, Karpenko O, et al. Cytokine and chemokine profiles in fibromyalgia, rheumatoid arthritis and systemic lupus erythematosus: a potentially useful tool in differential diagnosis. Rheumatol Int (2015) 35:991–996 DOI 10.1007/s00296-014-3172-2.