Exagen entered into an exclusive worldwide license agreement with the Ohio State Innovation Foundation to develop and market a blood test that can distinguish fibromyalgia from other disorders, allowing for an earlier diagnosis.
Fibromyalgia is the most frequent cause of chronic musculoskeletal pain in the U.S. Yet, current estimates indicate that as many as 12 million people with fibromyalgia may remain undiagnosed, the company stated.
The lack of reliable biomarkers is a significant challenge for timely diagnosis and treatment of this disorder. In particular, fibromyalgia may be misdiagnosed as an autoimmune rheumatic disease due to the common presence of antibodies that attack tissues and cause autoimmunity.
Researchers at The Ohio State University recently described molecular “fingerprints” unique to fibromyalgia, found using vibrational spectroscopy to analyze patients’ bloods samples. Vibrational spectroscopy identifies molecules by measuring their vibrations when absorbing energy. Each type of chemical bond in a molecule vibrates at a unique frequency, allowing extremely fine resolution of complex solutions like a blood sample.
Specifically, the scientists saw that people with fibromyalgia had a distinct metabolomic pattern — a set of metabolism products — compared with rheumatoid arthritis, osteoarthritis, and systemic lupus erythematosus.
“Patients with fibromyalgia and autoimmune diseases such as lupus and rheumatoid arthritis may have similar symptoms especially in early stage disease, making differential diagnosis difficult. A rule-in test for fibromyalgia would be a significant advancement in the earlier diagnosis and appropriate treatment of these patients,” Ron Rocca, president and CEO of Exagen, said in a press release.
Beyond the potential to give a yes-no diagnosis, data also showed a strong correlation between the metabolites identified in fibromyalgia patients and the intensity of their pain, as self-reported using the Revised Fibromyalgia Impact Questionnaire.
These findings suggest that vibrational spectroscopy can identify fibromyalgia and indicate pain levels.
According to the investigators, developing an objective and reproducible diagnostic tool for fibromyalgia could spare patients unnecessary testing, such as MRI scans and repeated blood draws, while also possibly aiding in treatment discovery.
“This research providing evidence that fibromyalgia can be detected in blood samples exemplifies Ohio State’s mission to improve lives by finding solutions to complex problems,” said Scott Osborne, Ohio State’s vice president of economic and corporate engagement.