EpicGenetics rolls out first fibromyalgia-specific blood Dx

Fibromyalgia, an awful state involving widespread pain and tenderness, is often diagnosed as something else before doctors come around to their final evaluation. EpicGenetics is hoping to address this with a definitive alternative, rolling out what it bills as the first diagnostic test that objectively identifies the condition using specific biomarkers.

The Santa Monica, CA, company's FM blood test earned its CLIA certification in 2012 and became commercially available earlier this month. And while the $744 test doesn't have widespread insurance coverage yet, EpicGenetics tells FierceMedicalDevices that it is meeting with insurers to pursue this, and can assist patients in seeking possible reimbursement in the interim if they choose.

In launching the diagnostic, EpicGenetics cites American College of Rheumatology statistics noting that patients who ultimately have fibromyalgia spend a small fortune and lots of time to get a diagnosis. According to those numbers, they put forth $4,800 and $9,300 annually over as many as three to 5 years on various diagnostic tests. Their symptoms are vague enough--chronic pain and fatigue, depression and insomnia among others--and often widely misunderstood.

After years, there are a few treatment options, such as Pfizer's ($PFE) Lyrica, a drug specifically approved to treat fibromyalgia as well as neuropathic and shingles-related pain. But the fact that there are any drugs to address the condition makes a solid diagnostic test all the more crucial. The earlier a fibromyalgia patient can correctly be identified, the sooner that patient can pursue treatment options that are available.

EpicGenetics says its FM Test works with 93% sensitivity, and the turnaround for results takes a week or less. The company also provides a questionnaire outlining symptoms to help patients see if they qualify. The University of Illinois College of Medicine at Chicago worked with EpicGenetics on a 200-patient study of the FM Test, which validated the idea that fibromyalgia patients have multiple biomarkers to test for. Among them: A dysregulation disorder in fibromyalgia patients affects their production of chemokines and cytokines, which are generated by white blood cells, as the company notes. These patients also have different immune system production patterns, which appear to contribute to stress, chronic pain and muscle tenderness, and other fibromyalgia-related symptoms.

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