SAN DIEGO—Exagen Diagnostics, Inc. announced today that the company has entered into an exclusive worldwide license agreement with the Ohio State Innovation Foundation. The agreement covers the commercial diagnostic development and marketing rights for a novel blood test using vibrational spectroscopy and metabolomic analysis to differentiate patients with fibromyalgia from rheumatoid arthritis, osteoarthritis, chronic lower back pain and systemic lupus erythematosus.
“Approximately thirty percent of fibromyalgia patients may test positive for anti-nuclear antibodies, raising autoimmune disease concerns and resulting in potentially inappropriate referrals to rheumatologists. In addition, 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,” said Ron Rocca, president and chief executive officer of Exagen. “A rule-in test for fibromyalgia would be a significant advancement in the earlier diagnosis and appropriate treatment of these patients.”
In the U.S., fibromyalgia is the most common cause of chronic widespread musculoskeletal pain. Approximately 90 percent of fibromyalgia sufferers are female, and there may be as many as 12 million people with undiagnosed fibromyalgia in the U.S. In a study authored by researchers from Ohio State University and recently published in The Journal of Biological Chemistry, scientists were able to distinguish clear metabolomic patterns that set fibromyalgia blood samples apart from those of other rheumatic diseases. The licensed technology is based on the research of Kevin Hackshaw, Luis Rodriguez-Saona and Tony Buffington at Ohio State.
“Fibromyalgia is often difficult to diagnose. 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,” added Scott Osborne, vice president of economic and corporate engagement at Ohio State.
Exagen also reported earlier in June that the company was beginning a clinical trial in collaboration with Duke University in Durham, North Carolina. The Duke Lupus Clinic is focused on diagnosing, treating and providing expert care to patients living with lupus. This prospective study will evaluate biomarkers — including the AVISE panel and Cell-Bound Complement Activation Products (CB-CAPs) — that distinguish between changes in subsets of lupus patients with Type 1 and Type 2 systemic lupus erythematosus (SLE) activity.
“We’re pleased to be partnering with Duke to study Exagen’s proprietary CB-CAPs biomarkers in patients with lupus,” stated Rocca in a press release. “A better understanding of the presentation and severity of lupus patients’ symptoms will help further the classification of disease severity.”
The Type 1 and Type 2 SLE model was developed at Duke University by Megan E.B. Clowse, M.D.; David Pisetsky, M.D., Ph.D.; Jennifer L. Rogers, M.D.; and their colleagues as a means to incorporate the full spectrum of lupus symptoms into the clinical assessment. It is also intended to advance personalized medicine for lupus patients.
The model combines patient- and physician- reported measures, and groups patients into two main categories. Type 1 manifestations are the classical lupus signs and symptoms due to inflammatory processes — including butterfly rash, joint inflammation, nephritis or vasculitis. Patients categorized as Type 2 have a general feeling of being unwell and may present with fatigue, depression, anxiety, widespread pain or difficulty sleeping.
“This collaboration will be the first to apply CB-CAPs to the Type 1 and Type 2 SLE model. When combined with clinical phenotyping, this study will determine whether the use of these biomarkers could lead to a more precision-medicine approach to lupus care and, potentially, improvements in patient outcomes,” noted Jennifer Rogers, director of the Duke Lupus Clinic.