Today with the assistance of major medical universities including UCLA, Massachusetts General Hospital and University of Illinois Chicago, EpicGenetics, Inc. announced the commencement of a new research study in fibromyalgia.
National Pain Report previously covered EpicGenetics’ FM/a® Test for the diagnosis of fibromyalgia, now, the company has announced they are seeking to make progress in uncovering information about FM that may, ultimately, help to provide a pathway for direct, effective treatment of the medical condition.
The study being announced will seek to do two things:
- identify genetic mutations unique to FM in up to 250,000 patients confirmed to have the medical condition via a positive FM/a® Test; and, based on these findings,
- explore a vaccine that could effectively treat and change the biology of fibromyalgia.
Fibromyalgia, is a painful, neurological disorder that, according to some estimates, may affect 10 million+ Americans. Still, there is limited research in and understanding of this medical condition, and fibromyalgia is too often misdiagnosed. Further, with limited treatment options and significant misunderstanding around fibromyalgia, patients are often told that they do not have a legitimate medical condition.
Although the test is not free, the company’s website claims that, a “growing numbers of patients are getting 100% insurance coverage” for the cost of the test, and they provide assistance in finding out whether an individuals insurance will cover the cost. Furthermore, according to their press release, “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.”
Additional information about the study announced today is in the press release below. More information can also be found at www.FMTest.com. And, the peer-reviewed research that was foundational to the FM/a® Test’s availability and effective use in diagnosing FM. (see “Peer-reviewed Medical Publications” in the page footer).
EpicGenetics, with the Assistance of Leading Medical Centers, Expands Clinical Study of FM/a® Test to Diagnose Fibromyalgia, Identify Genetic Markers Unique to the Disorder and Explore Direct Treatment Approaches
– Provides Research Gift to the Faustman Immunobiology Lab at Massachusetts General Hospital/Harvard Medical School to Support Research on Fibromyalgia Treatments –
LOS ANGELES – April 19, 2017 – EpicGenetics, a privately held biomedical company dedicated to improving the diagnosis and treatment of fibromyalgia, today announced that it has engaged the University of California, Los Angeles (UCLA)* and the University of Illinois College of Medicine Chicago (UIC). Both university research centers will be sequencing the exomes of patients to improve the diagnosis of fibromyalgia through the application of the FM/a® Test and to allow EpicGenetics to detect fibromyalgia disease-specific gene markers. Additionally, Bruce Gillis, M.D., CEO of EpicGenetics, has made a research gift to the Immunobiology Laboratory at the Massachusetts General Hospital directed by Denise Faustman, M.D., Ph.D., to continue its robust clinical research regarding a direct treatment for fibromyalgia.
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.
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 very little innovation over the past several decades to help patients better understand and manage their fibromyalgia,” said Frederick G. Behm, M.D., the Frances B. Geever Professor and head of pathology at the University of Illinois College of Medicine Chicago. “Patients with this disorder frequently experience pain and fatigue that prohibits them from being able to engage in their daily lives. These patients are seeking answers to basic questions about the cause and etiology of the disorder – and, as physicians, we are frustrated that our previously limited research in this field prevents us from being able to answer these questions.”
“Since becoming available in 2012, the FM/a® Test has successfully and objectively diagnosed patients with fibromyalgia in the U.S. and multiple other countries, thereby providing these patients with a definitive diagnosis and certainty about a medical condition that has often been misunderstood and erroneously denied as a legitimate medical disorder,” said Bruce Gillis, M.D., CEO of EpicGenetics. “I believe we are at the forefront of advancing scientific information about fibromyalgia and answering these critical questions for patients: 1) Do I have fibromyalgia? 2) How and why did I develop fibromyalgia? and 3) Is there a direct treatment for fibromyalgia?”
Denise Faustman, M.D., Ph.D., director of the Immunobiology Laboratory at the Massachusetts General Hospital and a noted immunologist at the Harvard Medical School, will initiate plans for a clinical trial at the Massachusetts General Hospital to test the potential of the Bacillus Calmette-Guérin (BCG) vaccine to change the biology 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.
As Dr. Faustman explains, “The Massachusetts General Hospital is announcing a new research effort on the application of the BCG vaccine, which will be directed at changing the biology of fibromyalgia as it concerns the foundational immune system discovery of the role particular cytokines have in fibromyalgia.”
The FM/a® Test will consequently not only serve to objectively confirm the diagnosis of fibromyalgia, but also act as the gateway for fibromyalgia patients through these newly announced research efforts to participate in genetic studies to further define their disease.
The cost of the FM/a® Test is covered by most insurance companies and Medicare.
Once diagnosed by the FM/a® Test, EpicGenetics will cover patients’ direct laboratory costs for the genetic surveys and for further research on their disease. Patients who are suspected of having fibromyalgia 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,[i] 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.[ii]
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. 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.