Bruce S. Gillis, MD, MPHTest identifies diagnostic biomarkers
BY KURT WOOCK
In the past, diagnosing fibromyalgia has been a cloudy subject, if not controversial. The symptoms are many and nebulous, leading some to believe the disease does not actually exist. Bruce S. Gillis, MD, MPH, was one of those people. A member of the clinical faculty at the University of Illinois College of Medicine (UIC) and founder of EpicGenetics, Santa Monica, Calif, Gillis was involved in a study that demonstrated fibromyalgia was indeed a disease—one that affected tens of millions of people. Researchers at the UIC Department of Pathology conducted a statistically significant study, comparing people clinically diagnosed with fibromyalgia to healthy patients. Gillis then helped develop the FM/a test, a simple blood test that objectively diagnoses fibromyalgia. He hopes the test will help end the stigma that often follows patients with fibromyalgia, and help provide them a cost- and time-saving method for diagnosis. He sat down with CLP to discuss these milestones.
CLP: What is your professional background in diagnostic testing?
Gillis: Back in 2005, I began a research program at the University of Illinois Chicago College of Medicine, where I’m on the faculty. We had been looking at developing diagnostic test scenarios where none existed yet; there is a much-expressed desire to have such tests to help unravel how you diagnose particular illnesses. Until you have an accurate diagnosis, you can never develop efficacious treatment.
CLP: How did you become involved in fibromyalgia research?
Gillis: We started on fibromyalgia just over 3 years ago. We first looked at chemical toxicity, and then we moved on to fibromyalgia. It was purely through serendipity. I was asked to evaluate 17 people who were all filing for disability for fibromyalgia. I was a fibromyalgia skeptic at the time. I think if you took a poll, nine out of 10 physicians would have agreed. I tried to see if there was a common denominator that would explain the symptoms that literally ranged from head to toe, starting with brain fog or mental confusion to musculoskeletal pain and tenderness to gastrointestinal discomfort. We developed a series of diagnostic tests to see if there was one particular immune process. We submitted an abstract to AACC in early 2012, and we won their award for outstanding research at their convention. We originally looked at those 17 patients and then performed our large, 200-plus-patient clinical study. Based on the dramatic results of that pilot study, we were a part of a much larger study with Dr [Frederick G.] Behm, one of the top pathologists in the US.
CLP: What were the findings?
Gillis: Fibromyalgia affects one out of 12 women, and one out of 20 men; over 20 million people total. By finding what we have, we are able to say, “Stop stigmatizing patients. These are not hysterical hypochondriacs. It’s not a problem relating only to women.” We are about to start a research program with Cornell. We feel there is a definite incidence of fibromyalgia in children.
CLP: And you not only have a better understanding of fibromyalgia—you developed a test for it.
Gillis: The test is critical. It’s the first known objective measurement for fibromyalgia. The sensitivity of the test exceeded 93%. As we do more tests, the sensitivity has been increasing to 99%. We feel that the greatest breakthrough is legitimizing the diagnosis.
CLP: What does the test consist of?
Gillis: We will send a test kit that has all the basic equipment in it. We collect two 9- to 10-mm tubes of blood. In that kit, you’ll find the standard tools for venipuncture. It comes in a special box that allows for you to send it back in a FedEx envelope that we provide. You can have your blood drawn at your own physician’s office, at a nearby draw station, or we will arrange for a licensed phlebotomist to come to your home or job site. Results are available in under a week. We are eager to arrange for licenses with private labs when they want to offer tests through their facilities.
CLP: What benefits does such a test bring to patients on day 1?
Gillis: It’s an accomplishment to offer the patients a simple, relatively inexpensive way to get diagnosed. You’ll find the average fibromyalgia patient, without access to this test, spends between $4,800 and $9,300 a year for between 3 to 5 years before they get a diagnosis. And they only get the diagnosis because of a process of elimination.
CLP: And you hope this test can lead to developments in treatment?
Gillis: We’re hoping we move in that direction. We hope the test may be a guidepost to therapy.
CLP: Are you involved at all in developing the treatment?
Gillis: What we are planning to do with professor Behm in Chicago is to start doing genomic studies on every patient who uses our diagnostic test. If we find gene markers, it would give us enough information for a drug company to say, “This is the pathway we need to work on for a curative approach.” We’re doing that at no additional expense to the patient. We feel this is our obligation.
CLP: What’s next for you and EpicGenetics?
Gillis: Since then, we’ve expanded. We’ve also been working on diagnostic testing for asthma at Harvard. We’re almost done with our initial analysis. We hope to submit a related manuscript in the next 90 days for publication.
Kurt Woock is the associate editor for CLP.
