Can A New Blood Test Objectively Prove Fibromyalgia?

As we’ve discussed in more detail in a previous post, fibromyalgia is a syndrome characterized by chronic, wide-spread muscle pain as well as fatigue, difficulty sleeping, depression or anxiety, muscle knots, cramping, or weakness, painful trigger points, and headaches.  Fibromyalgia can be difficult to diagnose, given the relative or subjective nature of most symptoms.  Symptoms can also mimic those of rheumatoid arthritis and other diseases, so often a diagnosis is established after other causes of symptoms are ruled out.  Doctors will examine a patient’s history, conduct a physical examination, as well as evaluate X-rays and blood work.  Doctors will also test patients for 18 tender points.  The American College of Rheumatology guidelines suggest that those with fibromyalgia have pain in at least 11 of these tender points.[1]

Although the majority of fibromyalgia cases are diagnosed chiefly by ruling out other conditions, many patients may now have access to a blood test that may diagnose the disease.  In 2012 a privately held biomedical company, EpicGenetics, released the FM/a® Test, which is an FDA-compliant blood test designed to diagnosis fibromyalgia.  The test identifies the presence of certain white blood cell abnormalities.[2] The use and accessibility of the test has been growing,  as Medicare and an increasing number of private insurance providers have begun covering the costs,[3] and the Civilian Health and Medical Program of the Department of Veterans Affairs (CHAMPVA) has also recently agreed to cover the cost of testing.[4]

The blood test works by analyzing protein molecules in the blood called chemokines and cytokines.  Founder and CEO of EpicGenetics, Bruce Gillis, MD, explains that those with fibromyalgia have a lower count of these protein molecules in their blood, leading to weaker immune systems.[5]  A diagnosis of fibromyalgia the traditional way can take, on average, more than two years.[6]  Many believe that FM/a® offers an objective and concrete diagnosis that allows sufferers to more quickly find adequate resources and treatment.

However, others argue that the test does not offer the diagnosis it promises.  Some argue that fibromyalgia is not a discrete medical condition but rather a “symptom cluster” or that the biomarkers the test identifies are also found in people with different illnesses, such rheumatoid arthritis.[7] As of this writing, major medical resource databases such as MedLine Plus, the CDC, and the Mayo Clinic continue to state that there is no lab test or definitive way to diagnose fibromyalgia.

As we’ve previously discussed, disability insurance policy holders can often face challenges with they go to file a claim based on disabilities, such as fibromyalgia, that are considered “subjective conditions.”  A test promising objective proof may remove some of these challenges. However, it remains to be seen how insurance companies and the medical community as a whole will agree on what constitutes objective proof of fibromyalgia, whether via this test or other medical advances down the road.

 

[1] 18 Points Used to Diagnose Fibromyalgia, Health, http://www.health.com/health/gallery/0,,20345635,00.html#where-does-it-hurt–1
[2] Businesswire, 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, Yahoo! Finance, Apr. 19, 2017, https://finance.yahoo.com/news/epicgenetics-assistance-leading-medical-centers-120000519.html
[3] Pat Anson, Fibromyalgia Blood Test Gets Insurance, Pain News Network, May 27, 2015, https://www.painnewsnetwork.org/stories/2015/5/27/fibromyalgia-blood-test-gets-insurance-coverage
[4] Emily Riemer, Mass General researcher investigating possible fibromyalgia vaccine, WCVB5, July 27, 2017, 6:05 p.m., http://www.wcvb.com/article/mass-general-researcher-investigating-possible-fibromyalgia-vaccine/10364683
[5] Anson, id.
[6] Getting a Diagnosis, Fibrocenter, http://www.fibrocenter.com/pain
[7] Anson, id.