Augurex’s Spondyloarthritis Test Earns FDA Breakthrough Status

Augurex Life Sciences has earned U.S. Food and Drug Administration (FDA) breakthrough device status for its SPINEstat 14-3-3eta autoantibody multiplex immunoassay test to diagnose patients with axial spondyloarthritis (axSpA).

AxSpA is a chronic, degenerative disease that causes persistent back pain in adults usually under age 45 and impacts millions of people globally. Although it is prevalent, patients often face diagnostic delays averaging seven to ten years—many patients are misdiagnosed with mechanical back pain. This can result in delayed therapeutic intervention and irreversible spinal damage.

SPINEstat is a multiplex immunoassay that measures autoantibodies to the 14-3-3eta protein. The test showed high specificity and sensitivity in differentiating axSpA from mechanical back pain in recent data reported at the American College of Rheumatology (ACR) Convergence conference.

The test complements existing diagnostic tools as well as signs, symptoms, and clinical findings. SPINEstat hopes to aid in clinical decision-making and expedited referrals to rheumatology care, reducing the uncertainty and extended diagnostic delay facing back pain patient who may be living with axSpA.

“Receiving FDA Breakthrough Designation for SPINEstat marks a major milestone for Augurex and an important step forward for patients living with inflammatory back pain,” said Neil Klompas, CEO of Augurex Life Sciences. “This recognition from the FDA underscores the potential of SPINEstat to close a long-standing diagnostic gap for this debilitating condition by providing patients and physicians with a new objective and specific tool to differentiate axSpA from mechanical back pain and access the appropriate medical care.”