EpicGenetics is collaborating with the University of California, Los Angeles (UCLA) and the University of Illinois College of Medicine Chicago (UIC) to gather genetic information from fibromyalgia patients to improve the diagnosis capacity of its FM/a Test. This goal of this project is to detect fibromyalgia disease-specific genetic markers.
Based on the quantification of several blood biomarkers that have been associated with fibromyalgia, the FM/a Test can accurately and objectively diagnose this medical condition. It is an FDA-compliant blood test that has been clinically validated, presenting a 93% sensitivity to diagnose fibromyalgia.
“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, CEO of EpicGenetics, in a press release.
The company will offer genetic screens to patients who tested positive with the FM/a test. This will allow the identification of specific disease-related mutations and genetic markers, similar to the BRCA1/BRCA2 predictive genes for breast cancer.
EpicGenetics’ associated CAMPAIGN 250 seeks to accomplish genetic screens in up to 250,000 fibromyalgia patients. The costs associated with the genetic tests and for further research on the disease will be covered 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, MD, 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.”
EpicGenetics also had established a protocol with Denise Faustman, MD, PhD, director of the Immunobiology Laboratory at Massachusetts General Hospital, in order to offer to all FM/a test-positive patients the opportunity to participate in a clinical trial on a potential vaccine for fibromyalgia.
“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” Faustman said.
Patients who do not know if they have fibromyalgia and want to use the FM/a Test need to request an authorization from their licensed healthcare practitioner. The costs of the FM/a Test are covered by most insurance companies and Medicare.