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

LOS ANGELES--(BUSINESS WIRE)--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.

To learn more about the FM/a^® Test and these clinical studies, including details on participation, please visit www.FMTest.com or http://www.facebook.com/TheFMTest.

About Fibromyalgia

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,¹ 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.²

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.

About EpicGenetics

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.

*UCLA has been engaged to sequence the exomes of research subjects.

ⁱ About Fibromyalgia: Prevalence. National Fibromyalgia & Chronic Pain Association. http://www.fmcpaware.org/fibromyalgia/prevalence.html.
ⁱⁱ Arnold LM, Clauw DJ, McCarberg BH, and FibroCollaborative. Improving the recognition and diagnosis of fibromyalgia. Mayo Clin Proc. 2011;86(5):457-464.