Many veterans developed fibromyalgia after being deployed to the Gulf. A test showing that a person has the disease qualifies them for veterans disability.
In addition, the test will qualify veterans with fibromyalgia for a clinical trial of a vaccine that may reverse the disease.
EpicGenetics developed the FM/a test in 2013. It is the first blood test the U.S. Food and Drug Administration has approved for diagnosing fibromyalgia.
The test includes a number of biomarkers. Together, they identify anomalies in the immune system’s white blood cells that show up in people with the disease.
A key reason the FDA approved the test is that is has an accuracy rate of 93 percent.
The Veterans Administration has recognized fibromyalgia as a Gulf War deployment condition that warrants disability status, which entitles veterans to a monthly stipend and special medical coverage.
Until EpicGenetics developed its test, it was hard for many Gulf War veterans to obtain fibromyalgia disability status, however — because proving they had the disease was often difficult.
The Veterans Administration recognized fibromyalgia as a Gulf War disability after research in the early 1990s showed that those deployed there were at increased risk of developing fibromyalgia and chronic fatigue syndrome.
To help Gulf veterans receive fibromyalgia-related disability status, Medicare, the Veterans Administration’s CHAMPVA health insurance program and most preferred provider organization insurance plans for veterans cover the FM/a test.
“We are proud that the FM/a test can play a role in helping our veterans not only accurately and definitively diagnose their fibromyalgia, but also enable Gulf War veterans to seek appropriate disability reimbursement for the disorder,” Dr. Bruce Gillis, the chief executive officer of EpicGenetics, said in a press release.
“Traditionally, fibromyalgia has only been diagnosed through a process of ruling out all other potential conditions, a costly and time-intensive process that has made it notoriously difficult to prove the presence of fibromyalgia for disability claims,” he said. “Now, veterans who are believed to have fibromyalgia can confirm their diagnosis and support their claim with this simple, objective blood test.”
An FM/a test showing that a veteran has fibromyalgia also makes them eligible to participate in a clinical trial that will evaluate whether a Bacillus Calmette-Guérin tuberculosis vaccination can reverse the disease.
Researchers are testing whether the BCG vaccine, which is almost a 100 years old, can treat several autoimmune diseases. BCG can correct protein abnormalities in white blood cells. If such abnormalities are the cause of fibromyalgia, then the vaccine could be a way to treat it.
The clinical trial will be in the United States. If it shows that BCG is effective against fibromyalgia, participants may be able to obtain a full treatment regimen.
If the vaccine turns out to be a successful treatment for fibromyalgia, it would eliminate the need for those with the disease to use medications, opioids and narcotics for their condition.
“We are hopeful that the initiation and subsequent findings of this clinical trial will result in the identification of an effective, direct treatment for fibromyalgia,” Gillis said. “With no effective treatment options currently available, these advancements have the potential to help millions of Americans, including thousands of our veterans, who suffer every day from common fibromyalgia symptoms such as chronic pain, fatigue and depression.”